Ex Parte Bergman et al

Board of Patent Appeals and Interferences

Jan 31, 2012

11470988 (B.P.A.I. Jan. 31, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/470,988 09/07/2006 Rolf Bergman 27570 8887
33357 7590 02/01/2012
ABBOTT MEDICAL OPTICS, INC.
1700 E. ST. ANDREW PLACE
SANTA ANA, CA 92705
EXAMINER
SHOMER, ISAAC
ART UNIT PAPER NUMBER
1612
MAIL DATE DELIVERY MODE
02/01/2012 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROLF BERGMAN, MARIA LUNDQVIST, STIG MANNBERG,
BJORN LUNDGREN, and ROBERT SHIMIZU
__________

Appeal 2011-013450
Application 11/470,988
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
JACQUELINE WRIGHT BONILLA Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to
an ophthalmic formulation. The Examiner has rejected claims 1-9 and 11-29
as obvious under 35 U.S.C. §103(a). We have jurisdiction under 35 U.S.C.
§ 6(b) (2011). We affirm.

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STATEMENT OF THE CASE
The invention relates to a formulation comprising a buffer, a tonicity
component, a first fraction of an ophthalmically acceptable compound and a
second fraction of an ophthalmically acceptable compound, where the two
ophthalmically acceptable compounds have average molecular masses that
differ by a certain molecular weight (e.g., at least 4 or 5 million Daltons)
and/or are present in certain mg/ml concentrations (e.g., 10 mg/ml total).
Appellants have appealed rejections of claims 1-9 and 11-29, which
all recite a formulation. (See App. Br. 2.) Independent claims 1 and 11 are
representative and read as follows (emphasis added):
1. A formulation comprising:
a composition having a buffer to maintain pH;
a tonicity component to control osmolality;
a first fraction of a first ophthalmically acceptable compound; and
a second fraction of a second ophthalmically acceptable compound,
wherein the first and second fractions are internally compatible
with one another are in solution and are present in a total
concentration of at least 10 mg/ml, and the first and second
fractions have average molecular mass that differ by at least 4
million Daltons to achieve both dispersive and cohesive properties
whereby the concentration and molecular mass are adjusted to
determine either dispersive or cohesive properties of the compound
as desired for a procedure.
11. A formulation comprising at least 5 mg/ml each of first and
second ophthalmically acceptable, viscoelastic compounds, a
buffer and tonicity components, the first compound having an
average molecular mass of less than 150,000 Daltons, and the
second compound having an average molecular mass of at least 2
million Daltons whereby the combination of the first and second
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ophthalmically acceptable compounds provide a beneficial
rheological property affecting rheology and viscosity based on
adjusted desired concentrations and molecular mass of the first and
second ophthalmically acceptable compounds.
The claims stand rejected as follows:
• Claims 1-7, 9, 13-21, and 23-29 under 35 U.S.C. §103(a) as being
rendered obvious over Francese et al. (U.S. Pat. No. 5,492,936, issued Feb.
20, 1996) (“Francese”) in view of Lindqvist et al. (U.S. Pat. No. 5,681,825,
issued Oct. 28, 1997) (“Lindqvist”).
• Claims 8, 11, 12, and 22 under 35 U.S.C. §103(a) as being rendered
obvious over Francese in view of Lindqvist, and in further view of Kwitko et
al. (The History of Modern Cataract Surgery, Kugler Publications, The
Netherlands 111-119 (1998)) (“Kwitko”).
Issues on Appeal
The first issue is whether Francese and Lindqvist, read in
combination, taught and/or suggested to one of skill in the art the
formulations recited in claims 1-7, 9, 13-21, and 23-29, and whether one
would have been motivated to make such formulations by, for example,
substituting a higher molecular weight compound (e.g., greater than 4.5
million Daltons) disclosed in Lindqvist in place of a 2-4 million Daltons HA
fraction disclosed in Francese.
The second issue is whether Francese, Kwitko and Lindqvist, read in
combination, taught and/or suggested to one of skill in the art the
formulations recited in claims 8, 11, 12, and 22, and whether one would
have been motivated to make such formulations by, for example,
substituting a lower molecular weight compound (e.g., 85,000 Daltons, i.e.
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less than 150,000 Daltons) disclosed in Kwitko in place of a 200,000
Daltons fraction disclosed in Francese.
Findings of Fact
1. Francese discloses “[n]ew compositions … useful to protect human or
animal ocular or eye cell layers and tissues subject to exposure to trauma,”
where the compositions “include two distinct molecular weight fractions of
alkali metal and/or alkaline earth metal hyaluronates.” (Francese, col. 2, ll.
39-47.)
2. In this context, Francese describes formulations comprising (1) a first
hyaluronate (hyaluronic acid or “HA”) fraction having a molecule weight of
at least 2 million Daltons, such as 2 million to 4 million, and (2) a lower
molecular weight HA fraction having a molecular weight of about 200,000
to 800,000 Daltons. (Id. at Abstract; see also col. 2, ll. 57-67.) Francese
also teaches that “[m]ore preferably, the present compositions include both a
buffer component and a tonicity adjuster component.” (Id. at col. 3, ll. 14-
20; see also col. 3, l. 66 – col 4, l. 6.)
3. Francese teaches that formulations comprising both a high molecular
weight HA fraction and a lower molecular weight HA fraction “provide
substantial advantages, e.g., in terms of providing adhesion and/or protection
to human or animal cell layers and tissues located in the eye which are
exposed to trauma, in particular during surgical procedures.” (Francese, col.
3, l. 66 – col 4, l. 9.) In addition, the compositions “also have other
properties useful in viscoelastic fluids, such as high viscosity at zero shear,
elasticity and pseudoplasticity.” (Id. at col. 4, ll. 9-12.)
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4. Examples in Francese refer to a Composition 1 comprising 5 mg/ml of
a sodium HA fraction having a weight average molecular weight of 3.5
million, and 15 mg/ml of a sodium HA fraction having a weight average
molecular weight of 500,000 (id. at col. 6, ll. 36-41). Examples compare
Composition 1 to comparative Compositions 2 and 3, which each comprise
only one sodium HA fraction. Composition 2 (Vitrax®) comprises 30
mg/ml of a fraction having a weight average molecular weight of 500,000,
while Composition 3 (Healon®) comprises 10 mg/ml of a fraction having a
weight average molecular weight of 3.5 million (id. at col. 6, ll. 42-54).
5. Francese teaches that:
the present compositions, exemplified by Composition 1, have benefits
of both compositions having only a mid-range molecular weight
hyaluronate fraction (as exemplified by Composition 2) and
compositions which have only a high molecular weight hyaluronate
fraction (as exemplified by Composition 3). As noted above, the
present compositions have very good flowability, for placement into
the eye through a cannula; very effectively maintain the anterior or
posterior chamber of the eye; and provide outstanding protection for
the corneal endothelium during eye surgery. Neither Composition 2
nor Composition 3 provide this advantageous combination of benefits.
(Id. at col. 7, l. 52 – col. 8, l. 2 (emphasis added).)
6. Francese also discloses that: “no substantial difference in
composition performance would occur by changing the weight average
molecular weight of the mid-range molecular weight hyaluronate fraction
within the range about 200,000 to 700,000 or about 800,000.” (Id. at col. 8,
ll. 7-11.)
7. Francese similarly discloses that: “no substantial difference in
composition performance would occur by changing the weight average
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molecular weight of the high molecular weight hyaluronate fraction within
the range of about 2 million to about 4 million or more.” (Id. at col. 8, ll. 11-
15.)
8. Lindqvist teaches a composition used in eye surgery operations, where
the composition includes a high molecular weight HA, e.g., 4.5 million to 12
million Daltons, such as 4.5 million to 8 million Daltons. (See Lindqvist
Abstract.) See also Lindqvist, col. 3, ll. 37-58; claims 2-3 (describing, for
example, HA having a weight average molecular weight “in particular” from
4.5 million to 6.5 million Daltons).
9. Lindqvist states that “an HA having a high viscosity and a high weight
average (4,000,000 to 12,000,000) can be quite satisfactorily used for
injection into the eye area during operations on the eye provided that the
zero shear viscosity of the HA injected into the eye area is in the range of
about 700 to about 20,000 Pas.” (Id. at col. 2, ll. 27-33.)
10. Lindqvist teaches that the “[n]ew high viscosity hyaluronic acid has
been found to be more beneficial in connection with phacoemulsification
surgery than the prior art products since it seems to protect the cornea much
better.” (Id. at col. 2, ll. 49-52.)
11. Lindqvist describes including a buffer in the disclosed composition.
(See id. at col. 3, ll. 29-32.)
12. Claim 4 presented in Lindqvist recites that “the hyaluronic acid has a
weight average molecular weight of between 4,700,000 and 5,700,000
daltons.” (Id. at col. 5, ll. 35-37.)
13. Like Francese and Lindqvist, Kwitko describes compositions for use
in eye surgery. In this context, Kwitko describes the use of several
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viscoelastic substances, such as (i) sodium HA (NaHa); (ii) hydroxypropyl-
methylcellulose (HPMC) having a molecular weight of 85 kDa; (iii) and
chondroitin sulfate (CDS) having a molecular weight of 20 kDa. (See
Kwitko, 112, 2
nd
col. – 114, 1
st
col; see also, 119, Table.)
14. Kwitko describes advantages of using each of these commercially
available substances. According to Kwitko, for example, HPMC can be
stored at room temperature, sterilized by autoclaving, and is lower in cost to
produce. (See Kwitko, 117, 2
nd
col.)
15. Kwitko describes the use of “Viscoat” that is a 1:3 mixture of 4%
CDS and 3% NaHa. “This combination tends to give it some viscous
properties of NaHa and, at the same time, the dispersive properties of CDS.”
(Kwitko, 117, 1
st
col.)
Principles of Law
A product-by-process claim is “one in which the product is defined at
least in part in terms of the method or process by which it is made.”
SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1315 (Fed. Cir.
2006) (quoting Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S.
141, 158 n. (1989) (quoting D. Chisum, Patents § 8.05, at 8-67 (1988)). “In
determining validity of a product-by-process claim, the focus is on the
product and not on the process of making it.” Amgen Inc. v. F. Hoffmann-La
Roche, Ltd., 580 F.3d 1340, 1369 (Fed. Cir. 2009) (citing Atl.
Thermoplastics Co. v. Faytex Corp., 970 F.2d 834, 841 (Fed. Cir. 1992)).
An old product is not patentable even if it is made by a new process.
“Because validity is determined based on the requirements of patentability, a
patent is invalid if a product made by the process recited in a product-by-
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process claim is anticipated by or obvious from prior art products, even if
those prior art products are made by different processes.” Amgen, 580 F.3d
at 1370, n.14.
Analysis
I.
Appellants appeal the Examiner‟s rejection of claims 1-7, 9, 13-21
and 23-29 as obvious over Francese in view of Lindqvist. As noted above,
claim 1 is representative of this group of claims. In relevant part, claim 1
recites a formulation comprising: (i) a buffer; (ii) a tonicity component; (iii)
a first fraction of a first ophthalmically acceptable compound; and (iv) a
second fraction of a second ophthalmically acceptable compound. The first
and second fractions are present in a total concentration of at least 10 mg/ml,
and have average molecular masses that differ by at least 4 million Daltons.
Claim 1 also recites that the two fractions differ in molecular weights
“to achieve both dispersive and cohesive properties whereby the
concentration and molecular mass are adjusted to determine either dispersive
or cohesive properties of the compound as desired for a procedure.” In
relation to this phrase, Appellants argue that “neither Francese… nor
Lindqvist… teach or suggest modulation
1
of the concentrations and
molecular masses for use with different type[s] of medical procedures.”
(App. Br., 8; see 11-12; see also Reply Br. 6-7.) Along similar lines,
Appellants state that “an important distinguishing feature of the present
invention is to provide the plurality of combinations to achieve the desired

1
Appellants also use similar phrasing such as “manipulation” or
“adjustment,” or “the ability to vary,” but the essential point is the same.
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rheological properties that may be beneficial for a particular medical
procedure.” (App. Br. 12; see also Reply Br. 7 (stating that the control of
percentages and concentrations of the fractions is unique).)
We note, however, that all pending claims relate to formulations, not
methods of making or using a formulation. Thus, the above-mentioned
“adjusted” phrase in claim 1 at most, corresponds to a product-by-process
limitation. As correctly noted by the Examiner, the patentability of a
product does not depend on its method of production. Ans., 8-9; see also
Amgen, 580 F.3d at 1369 (stating that “[i]n determining validity of a
product-by-process claim, the focus is on the product and not on the process
of making it”). Moreover, the “adjusted” phrase itself adds nothing to
indicate what the particular concentrations or molecular masses might be,
beyond what is stated elsewhere in the claim (i.e., at least 10 mg/ml total,
and molecular masses that differ by at least 4 million Daltons, as recited in
claim 1). Language such “as desired for a procedure” (claim 1) provides no
information in this regard, and therefore provides no further limitation to the
claims.
As such, the formulation of claim 1 essentially boils down to one that
comprises a buffer, a tonicity component, and a first fraction and second
fraction having a total concentration of at least 10 mg/ml, and average
molecular masses that differ by at least 4 million Daltons. Francese, as
noted above, expressly teaches relevant compositions for use in eye surgery
that include “both a buffer component and a tonicity adjuster component.”
(Francese, col. 3, ll. 14-20; see also col. 3, l. 66 – col 4, l. 6; FF 2.) In
addition, Francese‟s formulations comprise a first fraction having an average
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molecular mass of at least 2 million Daltons, such as 2 million to 4 million,
and a second fraction having an average molecular mass of about 200,000 to
800,000 Daltons. (See id. at Abstract, see also col. 2, ll. 57-67.) As such,
Francese does not explicitly refer to a first and second fraction having an
average molecular mass “that differ by at least 4 million Daltons.” (Claim
1.) While the difference between 4 million and 200,000 Daltons (i.e., 3.8
million Daltons) disclosed in Francese is close, it is not “at least 4 million”
per se.
Like Francese, Lindqvist discloses formulations for “facilitating
surgical operations that involve the eye.” (Lindqvist, Abstract.) Lindqvist‟s
formulations include a high molecular weight HA of 4.5 million to 12
million Daltons, such as 4.5 million to 6.5 million Daltons, or 4.7 million to
5.7 million Daltons. (See id. at col. 3, ll. 37-58; claims 3-4.) Lindqvist
teaches that the “[n]ew high viscosity hyaluronic acid has been found to be
more beneficial in connection with phacoemulsification surgery than the
prior art products since it seems to protect the cornea much better.” (Id. at
col. 2, ll. 49-52.) In other words, Lindqvist teaches one to use the disclosed
higher molecular weight HA in formulations for use in eye surgery.
As pointed out by the Examiner in the Answer on page 7, because
Lindqvist taught that a higher molecular weight HA was “more beneficial in
connection with phacoemulsification surgery than the prior art products”
(Lindqvist, col. 2, ll. 49-52), those skilled in the art would have been
motivated to substitute a higher molecular weight HA (>4.5 million Daltons)
for the 2 million to 4 million Daltons HA fraction disclosed in Francese.
The teaching in Francese of a fraction being “at least 2 million Daltons” did
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not preclude a difference of at least 4 million Daltons between two fractions,
and in fact suggested that “no substantial difference” would result from
including a fraction with a molecular mass that was “within the range of
about 2 million to about 4 million or more” (Francese, col. 8, ll. 11-15,
emphasis added). Thus, nothing in Francese or Lindqvist taught away from
substituting the higher molecular weight HA (>4.5 million Daltons) of
Lindqvist in place of the 4 million Daltons HA referenced in Francese when
preparing the formulation described in Francese. Moreover, Lindqvist
provided clear motivation to do such a substitution.
Appellants‟ arguments that neither Francese nor Lindqvist teach or
suggest modulating or “the ability to vary” concentrations and molecular
masses is not persuasive. One would have been motivated to read Francese
and Lindqvist together because these references both described HA
formulations for eye surgery. As discussed above, those skilled in the art
reading both Francese and Lindqvist would have been motivated to
substitute the higher molecular weight HA (>4.5 million Daltons, such as 4.5
to 6.5 million Daltons) disclosed in Lindqvist for the 4 million Daltons HA
fraction disclosed in Francese. Francese itself taught the use of a higher
molecular weight HA fraction of “at least 2 million” (Francese, Abstract).
Moreover, Francese taught that “no substantial difference in composition
performance would occur by changing the weight average molecular weight
of the high molecular weight hyaluronate fraction within the range of about
2 million to about 4 million or more” (id. at col. 8, ll. 11-15 (emphasis
added)).
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In addition, as noted by the Examiner, Francese taught “adjusting”
concentration and molecular masses, as done in Examples of this reference.
(See Ans. 11-12.) Francese also expressly stated that it found that
formulations comprising both higher and lower molecular weight fractions
“reduce, or even minimize or eliminate, the problems that often occur or are
present in compositions which contain only one of” of the fractions.
(Francese, col. 2, ll. 56-67.)
Regarding claim 13 (and claim 11, discussed in more detail ahead),
Appellants again argue that neither Francese nor Lindqvist, alone or in
combination, teach or suggest controlling the concentration and molecular
mass of the compounds “which may significantly impact the rheological
properties of the solutions, as required by Claim 11 and 13.” (App. Br. 12.)
Claim 13, for example, recites that the combination of the first and second
compounds “provide dispersive and cohesive properties by controlling the
percentages and concentrations of the fractions whereby the solution
characteristics will then be given different properties dependent on the
magnitude of the shear forces in action.”
Again, as discussed above, all pending claims recite formulations, not
methods. Thus, we do not consider an element reciting “provid[ing] … by
controlling the percentages and concentrations of the fractions …” to be
limiting in our patentability assessment of a claim directed to a formulation.
If it would have been obvious to one of skill in the art to make the claimed
formulation, it does not matter whether one would have “controlled” the
percentages and concentrations to give “the solution characteristics”
different properties, or not. “[A] patent is invalid if a product made by the
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process recited in a product-by-process claim is anticipated by or obvious
from prior art products, even if those prior art products are made by different
processes.” Amgen, 580 F.3d at 1370, n.14.
At most, the “controlled” or “adjusted” arguments by Appellants
relate to a motivation by one of skill in the art to prepare the formulations in
question. In this case, however, for the reasons discussed above regarding
claim 1, one would have been motivated to prepare the formulation recited
in claim 13, i.e., one comprising at least 5 mg/ml each of first and second
compounds, where the first compound had an average molecular mass of
less than 2 million, and the second compound had a higher molecular weight
(as taught in Francese), such as one of at least 5 million Daltons (as taught
and described as advantageous in Lindqvist; see, e.g., col. 3, ll. 37-40
(describing 4.5 million to 6.5 million Daltons HA compounds)).
Conclusion of Law
Because Francese, in view of Lindqvist, would have suggested a
formulation comprising a buffer, a tonicity component, and first and second
fractions that were present in a total concentration of at least 10 mg/ml (or 5
mg/ml each), and had average molecular mass that differed by at least 4 or 5
million Daltons, we agree with the Examiner that claims 1 and 13 were
obvious over these two references Claims 2-7, 9, 14-21 and 23-29 fall with
claim 1.
2

2
Although Appellants separately mention claims 23 and 26 in their
arguments (App. Br. 12), they only state that arguments presented with
respect to claim 1 also apply to claims 23 and 26. Appellants do not present
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II.
Appellants appeal the Examiner‟s rejection of claims 8, 11, 12 and 22
as obvious over Francese in view of Lindqvist, and in further view of
Kwitko Claim 11 is representative, and is the only independent claim in
this group. Claim 11 recites a formulation comprising at least 5 mg/ml each
of first and second compounds, a buffer and tonicity components, where the
first compound has an average molecular mass of less than 150,000 Daltons,
and the second compound has an average molecular mass of at least 2
million Daltons. Claim 11 also recites “whereby the combination of the first
and second … compounds provide a beneficial rheological property
affecting rheology and viscosity based on adjusted desired concentrations
and molecular mass of the first and second ophthalmically acceptable
compounds.”
The “whereby” clause quoted above provides, at most, a product-by-
process limitation. As suggested by the Examiner (Ans. 18, part D),
patentability of a product does not depend on its method of production. See,
e.g., Amgen, 580 F.3d at 1369. Moreover, the whereby phrase here adds no
information as to what the particular concentrations or molecular masses
might be, beyond what is stated elsewhere in the claim (i.e., at least 5 mg/ml
of each of the two compounds, and molecular masses of less than 150,000
Daltons and at least 2 million Daltons, respectively). Language reciting that
the combination “provide[s] a beneficial rheological property … based on

any arguments with respect to claims 23 and 26 that are not also presented
with respect to claim 1. Thus, claims 23 and 26 stand or fall with claim 1.
37 C.F.R. § 41.37(c)(1)(vii).
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adjusted desired concentrations and molecular mass” gives no additional
information, and therefore provides no further limitation to claim 11.
Thus, the formulation of claim 11 essentially boils down to one that
comprises a buffer, a tonicity component and a first and second compound,
where each of the compounds has a concentration of at least 5 mg/ml, and a
molecular mass of less than 150,000 Daltons and at least 2 million Daltons,
respectively. Francese, as noted above, teaches relevant compositions for
use in eye surgery that include “both a buffer component and a tonicity
adjuster component.” (Id. at col. 3, ll. 14-20; see also col. 3, l. 66 – col 4, l.
6.) In addition, Francese‟s formulations comprise a first compound having
an average molecular mass of at least 2 million Daltons, such as 2 million to
4 million Daltons, and a second compound having an average molecular
mass of about 200,000 to 800,000 Daltons. (Id. at Abstract, col. 2, ll. 57-
67.) As such, Francese does not explicitly refer to a smaller molecular
weight compound having an average molecular mass of “less than 150,000
Daltons.” While the 200,000 Daltons disclosed in Francese is close, it is not
“less than 150,000” per se.
We believe that the Examiner (Ans. 17 and 19) appropriately relies on
Kwitko for the teaching of a compound having an average molecular mass
of less than 150,000 Daltons. Kwitko describes different viscoelastics, such
as hydroxypropyl-methylcellulose (HPMC) having a molecular weight of 85
kDa, and chondroitin sulfate (CDS) having a molecular weight of 20 kDa,
that are used in cataract surgery. Kwitko, 112, 2
nd
col. – 114, 1
st
col; see
also, 119, Table. Thus, Kwitko discloses relevant compounds having an
average molecular mass of less than 150,000 Daltons. Moreover, Kwitko
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describes advantages of using the lower molecular weight compounds.
According to Kwitko, for example, HPMC can be stored at room
temperature, sterilized by autoclaving, and is lower in cost to produce. (See
Kwitko, 117, ¶ spanning 1
st
and 2
nd
col.)
Because Kwitko taught that HPMC, for instance, had “distinct
advantages … that have been used to market these products” (id. at 113, 2
nd

col.), those skilled in the art would have been motivated to substitute the
lower molecular weight HPMC (85,000 Daltons, i.e., less than 150,000
Daltons) in place of the 200,000 Daltons lower molecular weight fraction
when preparing the formulation disclosed in Francese. The teaching in
Francese of “about 200,000 to about 800,000, for example” with regard to
one of the fractions (see, e.g., Abstract) did not preclude using a smaller
molecular weight compound in its place. Moreover, Kwitko provided clear
motivation to do such a substitution. This is especially true in light of the
fact that Kwitko described the use of “Viscoat” having a 1:3 mixture of 4%
CDS (having a molecular weight of 20,000 Daltons, i.e., less than 200,000
Daltons) and 3% NaHa. As described in Kwitko, “[t]his combination tends
to give it some viscous properties of NaHa and, at the same time, the
dispersive properties of CDS.” Id. at 117, 1
st
col.
In response to the rejection, Appellants assert that “[m]erely having
dispersive and cohesive properties is not enough. The ability to adjust
(emphasis added) the desired concentrations and molecular mass to produce
greater cohesive and/or dispersive properties is not taught in Kwitko et al.”
(App. Br., 14 (emphasis in original); Reply Br. 9.) Again, we note that all
pending claims recite formulations, not methods. In a patentability
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assessment of the formulation of claim 11, we do not consider an element
reciting that the combination of the first and second compounds “provide[s]
a beneficial rheological property … based on adjusted desired concentrations
and molecular mass …” to limit the claimed composition. If it would have
been obvious to one of skill in the art to make the claimed formulation, it
does not matter whether one would have “adjusted” the percentages and
concentrations to “provide[] a beneficial rheological property,” or not. “[A]
patent is invalid if a product made by the process recited in a product-by-
process claim is anticipated by or obvious from prior art products, even if
those prior art products are made by different processes.” Amgen, 580 F.3d
at 1370, n.14.
In this case, for the reasons discussed above, one would have been
motivated to prepare the formulation recited in claim 11, i.e., one comprising
at least 5 mg/ml of each of two compounds, where one compound had an
average molecular mass of at least 2 million Daltons and the other
compound had a lower average molecular mass (as taught in Francese),
using, for instance, a compound having an average molecular mass of less
than 150,000 Daltons, as taught and described as advantageous in Kwitko.
See, e.g., Kwitko, page 113, 2
nd
col (describing advantages of using HPMC,
having a molecular weight of 85,000 Daltons); page 117, ¶ spanning 1
st
and
2
nd
cols. (describing advantages of Viscoat® comprising both CDS (having a
molecular weight of 20,000 Daltons) and NaHa).
Moreover, we agree with the Examiner (Ans., 17-18) that Kwitko
suggests adjusting concentrations and molecular masses when choosing a
viscoelastic for use during eye surgery. See, e.g., Kwitko, page 118, 1
st
col.
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18
(describing when to choose a cohesive viscoelastic versus a dispersive
viscoelastic); see also pages 116-17 (describing known examples of each
type of viscoelastic); page 111 (disclosing that “it is imperative to
understand the scientific basis for their design … and certainly the rheology
of viscoelastics”). As taught on page 114, 1
st
col., of Kwitko,
“[u]nderstanding the physical properties of viscoelastics allows selection of
a particular type of viscoelastic based on a specific surgical task.” See also
App. Br., 15; Reply Br. 9 (acknowledging that Kwitko teaches „“in the event
of unanticipated complications, or if a particular task so requires, the
surgeon should be ready to change the viscoelastic groups”‟).
Although Appellants assert that changing viscoelastic groups is not
the same as adjusting molecular masses and concentrations (App. Br., 15;
Reply Br., 9), Kwitko clearly describes molecular masses and concentrations
of different formulations, such as Viscoat®, and the relevance of molecular
weights and concentrations when choosing a formulation for eye surgery.
See, e.g., Kwitko, 113, 2
nd
col. (describing HPMC, its molecular weight and
viscoelastic properties) and page 117, spanning cols. (describing Viscoat®
in terms of concentrations of two different compounds, and how Viscoat®
has the highest viscosity at zero-shear rate). Thus, we agree with the
Examiner that one would have been motivated to substitute a relevant lower
molecular weight compound (i.e., less than 150,000 Daltons), such as
HPMC or CDS, as taught and described as advantageous in Kwitko, for the
lower molecular weight fraction (i.e., 200,000 Daltons) in the formulation
described in Francese.
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Conclusion of Law
Because Francese, in view of Kwitko, and in further view of
Lindqvist, would have suggested a formulation comprising a buffer, a
tonicity component, and at least 5 mg/ml each of a first and second
compound, where the first compound had an average molecular mass of less
than 150,000 Daltons, and the second compound had an average molecular
mass of at least 2 million Daltons, we agree with the Examiner that claim 11
was obvious over these references. Claims 8, 12, and 22 fall with claim 11.
SUMMARY
We affirm the rejection of claims 1-7, 9, 13-21 and 23-29 under 35
U.S.C. §103(a) as unpatentable over Francese in view of Lindqvist. We
likewise affirm the rejection of claims 8, 11, 12, and 22 under 35 U.S.C.
§103(a) as unpatentable over Francese in view of Kwitko, and in further
view of Lindqvist.

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).

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20
AFFIRMED

alw