Ex Parte Farnes et al

Patent Trial and Appeal Board

Oct 30, 2018

13446870 (P.T.A.B. Oct. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/446,870 04/13/2012
51957 7590 11/01/2018
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
FIRST NAMED INVENTOR
Eldon Q. Farnes
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.
18350CON2 (AP) 3685
EXAMINER
HUANG, GIGI GEORGIANA
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
11/01/2018 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):
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 ELDON Q. FARNES, MA YSSA ATTAR,
RHETT M. SCHIFFMAN, CHIN-MING CHANG,
RICHARDS. GRAHAM, and DEVIN F. WELTY
Appeal2017-002519
Application 13/446,870 1
Technology Center 1600
Before JEFFREY N. FRED MAN, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims a topical
aqueous ophthalmic solution, which have been rejected as obvious and for
obviousness-type double patenting. We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm.
STATEMENT OF THE CASE
"Ketorolac tromethamine 0.5% (w/v) ophthalmic solution ... is a safe
and effective NSAID [("nonsteroidal anti-inflammatory drug")] with proven
1 Appellants identify the Real Party in Interest as Allergan, Inc. (Appeal Br.
3.)
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analgesic and anti-inflammatory activity." (Spec. ,r 4.) According to
Appellants' Specification, though, a common side effect with that
formulation is ocular burning and stinging. (Id.) Appellants' Specification
acknowledges that 0.4% (w/v) ketorolac tromethamine ophthalmic solution
(ACULAR LS) has shown improved bioavailability and less stinging than
0.5% (w/v) ketorolac tromethamine ophthalmic solution (ACULAR). (Id.)
However, the Specification indicates that there is still a need for "an
improved ketorolac tromethamine formulation with greater bioavailability
and greater tolerability, minimized ocular surface toxicity, improved patient
comfort, increased retention time of the active ingredient and improved
wound healing capabilities during use." (Id.) The claimed invention seeks
to provide a formulation "to eliminate or reduce ocular irritation, to improve
tolerability, compliance, duration and effect of ketorolac, to allow for dosing
from four times daily to twice daily." (Spec. ,r 5.)
Claims 1-19 and 21-292 are on appeal. Claims 1 and 5 are
representative and read as follows:
1. A first composition for treating ocular pain and inflammation
following cataract surgery comprising 0.45% w/v ketorolac
tromethamine and about 0.5% w/v carboxymethyl cellulose.
5. The first composition of claim 3, wherein the 0.5% w/v
carboxymethyl cellulose is comprised of 0.325% w/v medium
viscosity carboxymethyl cellulose and 0.175% w/v high
viscosity carboxymethyl cellulose.
2 Appellants contend that claims 12 and 21-23 "are cancelled." ( Appeal Br.
5.) However, as of Applicants' last filed Amendment to the claims, dated
January 30, 2014, claims 1-19 and 21-29 were pending. No subsequent
formal paper has been filed by Applicants cancelling claims 12 and 21-23.
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(Appeal Br. 53.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 9, 10, 12, 14, 17, and 18 under pre-AIA 35 U.S.C. § I03(a) as
unpatentable over Vehige. 3
Claims 1-8, 11, 13, 16, 19, and 21-24 under pre-AIA 35 U.S.C.
§ I03(a) as unpatentable over Vehige and Chemg-Chyi. 4
Claim 15 underpre-AIA 35 U.S.C. § I03(a) as unpatentable over
Vehige, Chemg-Chyi, and Rowe. 5
Claims 25-29 under pre-AIA 35 U.S.C. § I03(a) as unpatentable over
Vehige, Chemg-Chyi, Rowe and Si. 6
Claims 1--4, 6-13, 16-19, and 21-23 underpre-AIA 35 U.S.C. §
I03(a) as unpatentable over Bhowmick. 7
Claims 5, 14, and 24 under pre-AIA 35 U.S.C. § I03(a) as
unpatentable over Bhowmick and Aqualon. 8
Claims 15 and 25-29 under pre-AIA 35 U.S.C. § I03(a) as
unpatentable over Bhowmick, Aqualon, and Rowe.
3 Vehige et al., US 2005/0031697 Al, published Feb. 10, 2005.
4 Chemg-Chyi et al., US 5,110,493, issued May 5, 1992.
5 Rowe et al., Handbook of Pharmaceutical Excipients: Sodium Citrate
Dihydrate (5th ed. 2006).
6 Si et al., US 7,141,607 Bl, issued Nov. 28, 2006.
7 Bhowmick et al., WO 2005/101982 A2, published Nov. 3, 2005.
8 Aqualon Sodium Carboxymethylcellulose: Physical and Chemical
Properties, Hercules Inc., 1999.
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Claims 1--4, 6-13, 16-19, and 21-23 underpre-AIA 35 U.S.C. §
I03(a) as unpatentable over Ousler. 9
Claims 5, 14, and 24 under pre-AIA 35 U.S.C. § I03(a) as
unpatentable over Ousler and Chang. 10
Claim 15 underpre-AIA 35 U.S.C. § I03(a) as unpatentable over
Ousler and Harting. 11
Claims 25, 26, 28, and 29 under pre-AIA 35 U.S.C. § I03(a) as
unpatentable over Ousler, Harting, and Si.
Claim 27 under pre-AIA 35 U.S.C. § I03(a) as unpatentable over
Ousler, Harting, Si, and Chang.
Claims 1-19 and 21-29 on the ground of non-statutory obviousness-
type double patenting as being unpatentable over claims 1-3 of US Patent
No. 7,842,714.
Claims 9, 10, 12, 14, and 17-18 on the ground of non-statutory
obviousness-type double patenting as being unpatentable over claims 1-6 of
US Patent No. 8,512,717.
Claims 1-19 and 21-24 on the ground of non-statutory obviousness-
type double patenting as being unpatentable over claims 1-10 of US Patent
No. 8,992,952.
Claims 1-19 and 21-29 on the ground of non-statutory obviousness-
type double patenting as being unpatentable over claims 1, 3---6, 9-15, 17-
22, and 24--31 of copending Application No. 12/552,057. 12
9 Ousler, III et al., US 2007/0254841 Al, published Nov. 1, 2007.
1° Chang et al., US 7,045,121 B2, issued May 16, 2006.
11 Harting et al., US 4,522,829, issued June 11, 1985.
12 Application 12/552,057 issued as US 9,192,571 on Nov. 24, 2015.
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Claims 1-19 and 21-24 on the ground of non-statutory obviousness-
type double patenting as being unpatentable over claims 1, 3-5, 7-15, and
17-20 of Application No. 12/953,622.
Claims 1-19 and 21-24 on the ground of non-statutory obviousness-
type double patenting as being unpatentable over claims 1, 3-5, 7-13, and
15-20 of Application No. 13/081,161.
Claims 1-19 and 21-29 on the ground of non-statutory obviousness-
type double patenting as being unpatentable over claims 1-29 of Application
No. 13/446,891.
Claims 1-19 and 21-24 on the ground of non-statutory obviousness-
type double patenting as being unpatentable over claims 21-24 of copending
Application No. 13/640,033.
Claim Construction Issues
Preamble
DISCUSSION
In general, the preamble limits a claim if it recites essential structure
or is otherwise "necessary to give life, meaning, and vitality" to the claim,
Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir.
1999) (quoting Kropa v. Robie, 187 F.2d 150, 152 (1951)), while the
preamble is not limiting when the claim body defines a structurally complete
invention and the preamble states only a purpose or intended use, Rowe v.
Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Here, the bodies of claims 1, 9,
19, and 25, which are each independent claims, define the requisite
components of the claimed compositions-specified amounts of ketorolac
and carboxymethyl cellulose ("CMC"), with claim 25 also specifying
amounts of sodium chloride and sodium citrate dihydrate-and we do not
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perceive, nor have Appellants explained, how stating that such compositions
are "for treating ocular pain and inflammation" excludes compositions that
would otherwise satisfy the recited structural requirements. Thus, we do not
find the preamble further limits the scope of protection as to the claimed
composition, and we do not give the preambles of these claims on appeal
patentable weight.
Wherein Clauses
We further note that certain of the composition claims recite
"wherein" clauses that are directed to stating properties of the recited
compositions when they are administered. In particular, certain claims recite
the (a) bioavailability effects obtained when the composition recited is
administered topically, see, e.g., claim 2, 6, 9, 10, 19, (b) reduction in ocular
pain and inflammation following surgery, see, e.g., claim 7, 8, 16, 29, or (c)
reduction in ocular pain and inflammation and resulting in less ( 1)
hyperemia or (2) burning or stinging than another ketorolac composition
even though the amount of ketorolac is higher than that other composition,
see, e.g., claim 17, 18. All properties of a composition are inherent in that
composition. See, e.g., In re Papesch, 315 F.2d 381,391 (CCPA 1963)
( emphasizing that "[ fJrom the standpoint of patent law, a compound and all
of its properties are inseparable; they are one and the same thing."). Thus,
"[p ]roducts of identical chemical composition cannot have mutually
exclusive properties." In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990).
Because none of the "wherein" clauses noted above recites any further
structural limitation to the elements of the composition or add additional
compositional elements, we do not give the clauses patentable weight in
considering whether or not the Examiner has made out a proper prima facie
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case ofunpatentability of these composition claims. Accord Honeywell Int'!
Inc. v. Mexichem Amanco Holding S.A. DEC. V., 865 F.3d 1348, 1355 (Fed.
Cir. 2017) ("What is important regarding properties that may be inherent,
but unknown, is whether they are unexpected. All properties of a
composition are inherent in that composition, but unexpected properties may
cause what may appear to be an obvious composition to be nonobvious.").
One claim, claim 13, recites "wherein" the composition is "used for
treating pain and inflammation following cataract surgery." This recited
intended use of the composition is not given patentable weight to the
composition claim, because "[ t ]he grant of a patent on a composition ...
cannot be predicated on a new use of that ... composition." In re Hack, 245
F.2d 246, 248 (CCPA 1957) ("As a matter of claim drafting, therefore, the
discoverer of a new use must protect his discovery by means of process or
method claims and not product claims.").
Obviousness: Vehige
Claim 9
The Examiner finds that Vehige teaches an ophthalmic composition
that includes a therapeutic component such as ketorolac, and a retention
component such as CMC. (Non-Final 13 3.) The Examiner notes that Vehige
teaches various ranges of the amount of the therapeutic in the composition,
the broadest of which is about 0.005% to about 30%, and a more narrow
range of 0.01 to about 1 %. (Id.) The Examiner also notes that Vehige
13 This Non-Final Action was mailed May 29, 2015, in response to
Applicants' filing of a request for continued examination under 3 7 CPR
1.114. (Non-Final 1-2.)
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teaches various ranges for the amount of CMC in the composition, the
broadest of which is at least about 0.01 %, and a more specific range of about
0.1 to about 5%. (Id.) The Examiner notes further that Vehige teaches that
the CMC in the composition can be a mixture of different molecular
weights, and that Vehige exemplifies compositions including a combination
of high molecular weight CMC ("HCMC") and medium weight CMC
("MCMC"). (Id.) The Examiner explains that while Vehige does not
specify the specific amount of ketorolac and CMC claimed, those amounts
are included within the narrow ranges taught by Vehige for both the
therapeutic and the retention component. The Examiner concludes that it
would have been obvious to one of ordinary skill in the art to have optimized
the amount of therapeutic and retention component to determine the
workable amounts of both and arrive at the claimed invention with a
reasonable expectation of success, in the absence of unexpected results.
(Id.) The Examiner explains that the desired results and properties recited in
the composition claims would necessarily result from the arrived at
composition given that such a composition would have all of the claimed
components of the composition in the claimed amounts. (Id. at 4--5.)
Appellants argue that it would not be routine experimentation to arrive
at the claimed amount ofketorolac and CMC because the person of ordinary
skill in the art would have to make too many choices in order to do so and
Vehige does not teach, suggest, or motivate that combination. (Appeal Br.
7.) According to Appellants, first one would have had to select ketorolac
from the "thousands of potential actives in Vehige" and then would have to
select 0.45% for the amount of ketorolac out of the "very broad range [of
from 0.01 - 1 %] with thousands of possible individual concentrations
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[ within it]." (Id.) Second, Appellants note that one would have to select
CMC from "numerous possible polyanionic components" disclosed and at
the specific concentration of 0.5%. (Id.)
We do not find Appellants' arguments persuasive for the reasons the
Examiner explained in the Examiner's Answer and as we discuss further
herein. (Ans. 41--45.) "It is well settled that a prior art reference is relevant
for all that it teaches to those of ordinary skill in the art." In re Fritch, 972
F.2d 1260, 1265 (Fed. Cir. 1992). Moreover, the normal desire of artisans to
improve upon what is already generally known is motivation to optimize
variables. See In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003). Thus,
it is generally considered that the discovery of an optimum value of a result-
effective variable of a known composition is within the skill of the art,
absent a showing of unexpected results. See, e.g., In re Boesch, 617 F .2d
272,276 (CCPA 1980).
Vehige is concerned with an ophthalmologic composition applied
topically that has improved delivery of therapeutics to the eye. (Vehige ,r 5.)
Vehige explains that the retention component of the composition assists in
facilitating administration of medication to the cornea, and that such a
composition permits reduced quantity of the therapeutic in the composition
to obtain a given therapeutic effect relative to a substantially identical
composition having no retention component. (Vehige ,r,r 6, 7, 36, 49.)
Vehige identifies ketorolac as a known ophthalmologic therapeutic
and also specifically claims a composition that includes that therapeutic
along with a retention component. (Id. ,r 119 and claim 24.) Additionally,
Vehige not only claims a composition where CMC is the retention
component, it exemplifies the use of that retention component ( as a blend of
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HCMC and MCMC) with a therapeutic. (Id. at Examples 1-8 and claim 12.)
Moreover, as the Examiner noted, Vehige teaches the therapeutic component
of the composition can be present in an exemplary range of from "about
0.01 % (w/v) to about 1.0% (w/v)" (id. ,r 164) and that the retention
component can be present in the composition in an exemplary range of from
"about 0.4% (w/v) to about 2.5% (w/v)" (id. ,r 112.) Thus, we agree with the
Examiner that Vehige' s teachings would have rendered obvious an
ophthalmologic composition that includes ketorolac as the therapeutic and
CMC as the retention component.
Regarding the claimed amounts of these two components, we note
Vehige teaches that "the total volume of composition that can be placed on
the eye without spillover after the drop is first applied and/or retention over
time of the composition to an ocular surface after the initial application
period are important factors for efficient delivery of a therapeutic component
to the eyes." (Id. ,r 50.) Vehige explains that the retention component of the
composition needs to be
effective to provide an increased total volume of a composition
to be retained on the ocular surface during and/ or after the
initial period after administration of the composition to an eye
by providing the present compositions with one or more of: a
reduced wettability, an increased meniscus height on the cornea
of the eye, an increased muco-adhesion, an increased or
substantially optimized viscosity and an increased physical
apposition or layering on a cornea of an eye.
(Id. ,r 51.) Thus, the retention component is a known result-effective
variable of the composition, and it would have been obvious to one of
ordinary skill in the art to optimize that component in the composition as the
Examiner explained.
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Furthermore, Vehige teaches that "[ t ]he therapeutic component [ of the
composition] may be such as to provide a desired therapeutic effect to the
eye." (Id. ,r 35.) And as noted, Vehige also teaches that the retention
component can reduce the amount of therapeutic component of a similar
therapeutic composition lacking the retention component. (Id. ,r 36.) Thus,
the amount of therapeutic in the composition is also a known result-effective
variable of the composition, and it would have been obvious to one of
ordinary skill in the art to optimize that component in the composition as the
Examiner explained. Thus, we agree with the Examiner that it would have
been obvious to select both ketorolac as the therapeutic ingredient and CMC
as the retention component in light of the teachings of Vehige and, through
optimization, arrive at the claimed amount of each ingredient absent a
showing of unexpected results. "[W]here there is a range disclosed in the
prior art, and the claimed invention falls within that range, there is a
presumption of obviousness." Iron Grip Barbell Co. v. USA Sports, Inc.,
392 F.3d 1317, 1322 (Fed. Cir. 2004).
Appellants argue that evidence of unexpected results is presented in
the record. We disagree that Appellants' evidence weighs in favor of
concluding that the claimed invention is non-obvious over Vehige. "[W]hen
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art." In re
Baxter Travenol Labs., 952 F.2d 388,392 (Fed. Cir. 1991). Appellants'
comparison was made against two commercially available compositions
containing ketorolac, ACULAR ( containing 0.5% w/v ketorolac) and
ACULAR LS (containing 0.4% w/v ketorolac), but neither of those
compositions contained CMC. (Appeal Br. 9--10 (noting that test results are
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provided for the comparison against ACULAR LS, while "paragraph 26 of
the present application explain[s] the unexpected results over ACULAR").)
Vehige teaches ophthalmologic compositions for topical administration that
include retention components like CMC and a therapeutic compound
provide an enhanced therapeutic effect of the therapeutic compound relative
to one without a retention component (Vehige ,r 36 and examples 1-8). It is
true that Vehige does not exemplify a composition containing ketorolac, but
it nevertheless teaches that use of CMC with a different known
ophthalmologic therapeutic, bimatoprost, allows for a reduced amount of
therapeutic to achieve the same results. (Vehige at Examples 1-8.)
Moreover, Vehige tests a second compound having a different chemical
structure than bimatoprost, brimonidine tartarate (Vehige at Example 10),
and observes the same result. The fact that Vehige demonstrates the same
result for two chemically different therapeutics in a topical ophthalmological
formulation reasonably suggests that the CMC "allow[ s] for much more of
the therapeutic component that is administered to the eye to actually pass
through, or penetrate the cornea, rather than being washed away by the
natural processes of the eye of' (Vehige ,r 3 6), and that such would be the
result when using any one of the therapeutic components disclosed in
Vehige, including ketorolac (Vehige ,r 119).
In other words, Vehige suggests an enhanced bioavailability of an
ophthalmologic therapeutic when used in a composition that includes CMC
and is applied topically. Appellants have not provided any evidence that
would indicate a reason one of ordinary skill in the art would not reasonably
expect improved bioavailability when ketorolac is combined with CMC, as
suggested by Vehige in the ranges disclosed. Instead, Appellants simply
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assert that "[i]t is doubtful that any of the other retention components in
Vehige would have this extreme effect." (Appeal Br. 11.) "[I]t is well
settled that unexpected results must be established by factual evidence.
'Mere argument or conclusory statements ... does not suffice."' In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). Absent a comparison of the
claimed amount of CMC and ketorolac to a composition of ketorolac in a
known therapeutic amount combined with CMC in the amounts of
therapeutic and CMC exemplified in Vehige, for example, demonstrating
unexpectedly improved bioavailability, we agree with the Examiner that
Appellants have not demonstrated evidence of unexpected results for the
claimed values over the closest prior art.
For the reasons discussed above, Appellants do not persuade us that
the Examiner erred in rejecting claim 9 as being obvious over Vehige.
Claim 12 has not been argued separately and therefore falls with claim
9. 37 C.F.R. § 4I.37(c)(l)(iv).
Claim 14
Appellants acknowledge that Vehige does teach mixtures of MCMC
and HCMC and varying mixtures of the two. (Appeal Br. 11.) However,
Appellants argue that there is no teaching or suggestion of the recited
HCMC and MCMC amounts in Vehige and that a composition with the
claimed amounts ofketorolac, HCMC, and MCMC would not be a matter of
routine optimization. (J d.)
We do not find Appellants' argument persuasive. As discussed above,
with respect to claim 9, Vehige demonstrates that mixtures of HCMC and
MCMC would result in the desired retention aspect that provides for use of a
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smaller amount of the therapeutic composition to the eye than would be
required to produce the same beneficial effect utilizing a substantially
identical composition without the retention component. (Vehige at Example
1.) Furthermore, Vehige teaches that inclusion ofMCMC with HCMC
results in a benefit to the patient over the inclusion of just HCMC, namely,
regaining clear vision more rapidly after administration of the composition.
(Id. ,r 204.) Moreover, Vehige demonstrates that varying the amounts of
different CM Cs while keeping the total amount of CM Cs constant also
achieves the desired therapeutic benefit. (Vehige at Examples 2-7.)
Consequently, we agree with the Examiner (Non-Final 4), that one of
ordinary skill in the art would have found it obvious to optimize the amount
ofHCMC and MCMC resulting in the claimed amounts with a reasonable
expectation of success.
Appellants rely on the same comparison discussed above with respect
to claim 9 as evidence of unexpected results. (Appeal Br. 11.) For the
reasons already discussed above, we do not find this evidence to be a
comparison of the closest prior art or persuasive to establish non-
obviousness when considered along with the teachings of Vehige.
In light of the foregoing, Appellants do not persuade us that the
Examiner erred in rejecting claim 14 as being obvious over Vehige.
Claims 10, 17, and 18
Appellants argue that claims 10, 17, and 18 are inventive over Vehige
because V ehige does not teach or suggest the composition of claim 9 that
has the claimed properties (increased bioavailability of ketorolac ( claim 10),
reduced ocular pain and inflammation and less hyperemia ( claim 17),
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reduced ocular pain and inflammation and less ocular burning and stinging
(claim 18)). (Appeal Br. 11, 12.) We do not find Appellants' argument
persuasive. For the reasons discussed above, we agree with the Examiner
that the composition of claim 9 is obvious from the teachings of Vehige and
Appellants have not established unexpected results. None of claims 10, 17,
or 18 require further compositional elements beyond that required by claim 9
so as to achieve the claimed properties. As explained in the claim
construction section above, we determine that the "wherein" clauses of these
claims are not entitled to patentable weight. Because the compositional
elements of claims 10, 17, and 18 are rendered obvious by Vehige, one of
ordinary skill in the art would expect the functional requirement of claims
10, 17, and 18 to be achieved as well. Spada, 911 F.2d at 709 ("[p]roducts
of identical chemical composition cannot have mutually exclusive
properties").
For the reasons discussed above, Appellants do not persuade us that
the Examiner erred in rejecting claims 10, 17, and 18 as being obvious over
Vehige.
Obviousness: Vehige and additional references
Claim 1
The only difference in the Examiner's rejection of claim 1 from claim
9 is that the Examiner notes that V ehige does not expressly teach the
tromethamine form of ketorolac. (Non-Final 8.) The Examiner relies on
Chemg-Chyi for teaching that it was known at the time of the claimed
invention that ketorolac tromethamine was a useful ophthalmic form of
ketorolac. (Id.) The Examiner concludes that it would have been obvious to
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one of ordinary skill in the art to use ketorolac tromethamine as the
therapeutic ketorolac in the composition ofVehige. (Id.)
Appellants contest the Examiner's rejection for the same reasons
discussed above with respect to claim 9. (See Appeal Br. 12-13 ("Chemg-
Chyi does not provide the missing motivation and does nothing to cure the
deficiencies of the Vehige reference in obviating the claimed invention."),
id. at 14--15.) For all of the reasons discussed above with respect to claim 9,
we do not find Appellants' arguments persuasive.
Moreover, we note that Chemg-Chyi teaches a composition that
includes ketorolac tromethamine at 0.5% w/v. (See, e.g., Chemg-Chyi 5:30-
4 7.) Thus, while it may be the case, as Appellants argue, that V ehige does
not identify 0.01 % to about 1.0% (w/v) as the preferred range (Appeal Br.
9), Chemg-Chyi, nevertheless, would have provided one of ordinary skill in
the art with a starting point of a known therapeutic amount of ketorolac
tromethamine from which to begin routine optimization within the O.01 % to
about 1.0% (w/v) range disclosed as one embodiment for the therapeutic in
Vehige. And, given Vehige's teaching that the use of CMC would
reasonably provide for the use of lower amounts of therapeutic and still
achieve the same therapeutic effect as the higher amount in a composition
that does not include CMC, we conclude that one of ordinary skill in the art
would have found it obvious to test formulations with amounts of ketorolac
tromethamine less than 0.5% in the routine optimization process.
For the reasons discussed above, Appellants do not persuade us that
the Examiner erred in rejecting claim 1 as being obvious over Vehige and
Chemg-Chyi.
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Claims 3 and 4 have not been argued separately (see, e.g., In re Lovin,
652 F.3d 1349, 1357 (Fed. Cir. 2011) (explaining that separately arguing a
claim requires more substantive arguments in an appeal brief than a mere
recitation of the claim elements and a naked assertion that the corresponding
elements were not found in the prior art"), and therefore fall with claim 1.
37 C.F.R. § 4I.37(c)(l)(iv).
Claims 2, 6-8, 11, 13, 19, 22, and 23
Appellants argue that claims 2, 6-8, 11, 13, 19, 22, and 23 are
inventive over Vehige and Chemg-Chyi because Vehige and Chemg-Chyi
do not teach or suggest the composition of claim 1 results in increased
bioavailability of ketorolac ( claims 2, 6, 11, 19), reduced ocular pain and
inflammation following cataract surgery ( claim 7, 8, 13, 16), reduced ocular
pain and inflammation and less hyperemia ( claim 22), reduced ocular pain
and inflammation and less ocular burning and stinging (claim 23)). (Appeal
Br. 15-20.) We do not find Appellants' arguments persuasive. None of
claims 2, 6-8, 11, 13, 19, 22, or 23 require further compositional elements
beyond that required by claim 1 so as to achieve the claimed properties. As
explained in the claim construction section above, we determine that the
"wherein" clauses of these claims are not entitled to patentable weight.
Because the compositional elements of claims 2, 6-8, 11, 13, 19, 22, and 23
are rendered obvious by Vehige and Chemg-Chyi, for the reasons discussed
above, one of ordinary skill in the art would expect the functional
requirement of claims 2, 6-8, 11, 13, 19, 22, and 23 to be achieved as well.
Spada, 911 F.2d at 709.
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For the reasons discussed above, Appellants do not persuade us that
the Examiner erred in rejecting claims 2, 6-8, 11, 13, 19, 22, and 23 as being
obvious over Vehige and Chemg-Chyi.
Claims 5 and 24
Appellants' arguments as to claims 5 and 24 rely on those made
regarding claim 14. (See, e.g., Appeal Br. 16 ("As stated in the previous
rejection, there is no teaching or suggestion in Vehige of a 0.325% w/v
medium viscosity CMC and a 0.175% high viscosity CMC. Chemg-Chyi
does nothing to teach the use of CMC and mixtures of CMC.").) For the
reasons discussed with respect to claim 14, we also do not find Appellants'
argument persuasive as to claim 5 or 24.
Claim 15
Appellants argue that "Rowe does not add any teaching to the analysis
of Vehige in view of Chemg-Chyi or supply the missing motivation which
would obviate applicants' claimed invention to arrive at the invention of
claim 15, which depends from claim 9." ( Appeal Br. 22.) This is not
deemed to be a separate argument for patentability of this claim, see, e.g.,
Lovin, 652 F.3d at 1357, and, thus, claim 15 falls with claim 14.
Claims 25-29
Appellants rely on the same arguments made with respect to claims 9
and 1 as to why the amount ofketorolac tromethamine and CMC recited in
claims 25-29 are not obvious. (Appeal Br. 23.) Regarding, the additional
requirement of 0.7% w/v NaCl in these claims, Appellants argue that Si,
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which "is mainly directed to suspensions," teaches a broader osmolality
range than the at least 200 mOsM taught by Vehige and that the range of
NaCl taught to be used in Si is a broad range and that numerous other salts
are taught that could be used. (Id. at 22-23) Thus, Appellants contend that
it would not be routine optimization to arrive at the claimed 0.7% of NaCl.
(Id. at 23.)
We do not find this argument persuasive because, as noted above, the
normal desire of artisans to improve upon what is already generally known
is motivation to optimize variables. See Peterson, 315 F.3d at 1330.
Appellants have not provided sufficient evidence of unexpected results
regarding the claimed components for the reasons discussed above
concerning claim 9.
Thus, Appellants do not persuade us that the Examiner erred in
rejecting claims 25-29 as being obvious over Vehige, Chemg-Chyi, Rowe,
and Si.
Obviousness: Bhowmick
Claim 1
The Examiner finds that Bhowmick teaches an ophthalmic
composition comprising ketorolac or its salts in the range from about 0.005-
about 1 %w/v, with CMC in the preferred range of from about 0.1---0.5%.
(Non-Final 12.) The Examiner notes that, like Vehige, Bhowmick does not
specifically teach the composition having the claimed values of ketorolac
and CMC. (Id.) However, as with the rejection of the claims over Vehige,
the Examiner finds that it would have been obvious to optimize the amounts
of these ingredients with a reasonable expectation of success. (Id. at 12-13.)
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Appellants' arguments against the obviousness of the claims over
Bhowmick are the same arguments made concerning the obviousness of the
claims over Vehige. (Appeal Br. 24--26.) We do not find Appellants'
arguments persuasive regarding the Bhowmick rejections either. Here again,
we have ranges disclosed in the prior art, where the claimed invention falls
within those disclosed ranges. The invention is therefore presumed obvious.
See Iron Grip, 392 F.3d at 1322.
In particular, Bhowmick teaches that acidic drugs, like most NSAIDS,
are irritating to the eye, causing discomfort such as stinging and excessive
tear generation. (Bhowmick 1.) Bhowmick discloses using cellulose
derivatives such as CMC to arrive at a stable ophthalmic composition with
an NSAID, such as ketorolac tromethamine, that does not cause stinging or
burning, or excessive tear generation. (Id. at 3--4.) Bhowmick teaches the
range of ketorolac may be "from about 0.005% to about 1 % w/v," and
exemplifies a composition that includes 0.5% ketorolac tromethamine. (Id.
at 3, 6-7.) Bhowmick further teaches that the preferred amount of cellulose
derivative is "an amount ranging from about 0.1 % to about 0.5%w/v." (Id.
at 4.) Bhowmick exemplifies the use of hydroxypropyl methylcellulose
(HPMC) at 0.15% w/v in a ketorolac tromethamine (0.5% w/v) composition,
and the resulting composition was shown to be less irritating when applied
as compared to ACULAR. (Id. at 6-8.) Given that Bhowmick teaches there
is a range of a useful amount of cellulose derivative and ketorolac, we
conclude that Bhowmick recognizes, like Vehige, that these are result-
effective variables in the composition to achieve a therapeutic composition
that was less irritating to the eye when applied thereto. Bhowmick's
disclosure of a list of possible cellulose derivatives to use would also
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indicate that Bhowmick considered this to be a result-effective variable.
Consequently, we agree with the Examiner that it would have been obvious
to optimize the amount of ketorolac tromethamine and CMC and arrive at
the claimed amounts with a reasonable expectation of success. See, e.g.,
Peterson, 315 F.3d at 1330; Boesch, 617 F.2d at 276.
Appellants' reliance on the comparison of the claimed composition to
ACULAR and ACULAR LS is not a comparison of the closest prior art.
There is no requirement that the closest prior art be commercialized. See In
re Merchant, 575 F.2d 865, 869 (CCP A 1978) ("In In re Wright . .. , failure
of a particular reference to constitute the commercial standard did not
diminish its position as the closest prior art.") Bhowmick teaches inclusion
of a cellulose derivative. Appellants' comparator does not include a
cellulose derivative. Thus, the comparison does not speak to whether or not
the bioavailability is unexpectedly better with CMC as compared to the
closest prior art composition disclosed in Bhomwick that includes a different
cellulose derivative. BMS, 752 F.3d at 977.
Thus, Appellants do not persuade us that the Examiner erred in
rejecting claim 1 as being obvious over Bhowmick.
Claims 2--4 and 9--12 have not been argued separately (see, e.g.,
Lovin, 652 F.3d at 1357 (explaining that separately arguing a claim requires
more substantive arguments in an appeal brief than a mere recitation of the
claim elements and a naked assertion that the corresponding elements were
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not found in the prior art"), and therefore fall with claim 1. 3 7 C.F .R.
§ 4I.37(c)(l)(iv). 14
Claims 6-8, 13, and 16-19
Appellants argue that claims 6-8, 13, and 16-19 are inventive over
Bhowmick because it does not suggest the composition of claim 1 or 9 has
the claimed properties (increased bioavailability of ketorolac ( claims 6, 19),
reduced ocular pain and inflammation following cataract surgery ( claim 7, 8,
13, 16), reduced ocular pain and inflammation and less hyperemia ( claim
17), reduced ocular pain and inflammation and less ocular burning and
stinging (claim 18)). (Appeal Br. 27-30.) We do not find Appellants'
arguments persuasive. For the reasons discussed above, we agree with the
Examiner that the composition of claims 1 and 9 are obvious from the
teachings of Bhowmick and Appellants have not established unexpected
results. None of claims 6-8, 13, or 16-19 require further compositional
elements beyond that required by claims 1 or 9 so as to achieve the claimed
properties. As explained in the claim construction section above, we
determine that the "wherein" clauses of these claims are not entitled to
patentable weight. Because the compositional elements of claims 6-8, 13,
and 16-19 are rendered obvious by Bhowmick, one of ordinary skill in the
art would expect the functional requirement of claims 6-8, 13, and 16-19 to
be achieved as well. Spada, 911 F.2d at 709.
14 Appellants separately argue that claims 14 and 15 are not obvious over
Bhowmick alone. (Appeal Br. 28.) However, the Examiner did not reject
these claims over Bhowmick alone. (See Non-Final 12.)
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For the reasons discussed, therefore, Appellants do not persuade us
that the Examiner erred in rejecting claims 6-8, 13, and 16-19 as being
obvious over Bhowmick
Obviousness: Bhowmick and additional references
Claims 5, 14, and 24
The Examiner notes that Bhowmick does not teach a mixture of
MCMC and HCMC. (Non-Final 13.) The Examiner explains though that
Bhowmick teaches inclusion of CMC "and cellulose embodiments with
viscosity ranges." (Id.) The Examiner notes that Aqualon teaches that there
are three different commercial viscosity types of CMC: HCMC, MCMC,
and low viscosity CMC and that any two viscosity types of CMC can be
blended to yield an intermediate viscosity. (Id. at 14.) The Examiner further
notes that Aqualon provides a blending chart and equation from which one
may determine the amounts of two known viscosity types of CMC to
achieve a desired viscosity. (Id.) The Examiner concludes from these
teachings that it would have been obvious to one of ordinary skill in the art
to blend known viscosity types such as HCMC and MCMC and produce the
claimed invention as a matter of optimization with a reasonable expectation
of success. (Id.)
Appellants argue that nothing in Bhowmick suggests mixtures of
HCMC and MCMC in the amounts claimed (Appeal Br. 28) or in Aqualon
and that nothing in Aqualon would lead one of skill in the art to arrive at the
mixture of CM Cs claimed in the respectively claimed amount (Appeal Br.
30-31 ). We agree with Appellants that the Examiner has failed to make a
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prima facie case of obviousness for claims 5, 14, and 24 over Bhowmick and
Aqualon.
In particular, while Bhowmick teaches that mixtures of cellulose
derivatives identified in a particular list can be combined, it does not suggest
a mixture ofHCMC and MCMCs. We do not agree with the Examiner that
the disclosure in Bhowmick that HPMC, in a variety of viscosity ranges,
(Bhowmick 4) may be used in the composition would have suggested that
combining HCMC and MCMC would also be suitable. In particular,
Bhowmick does not teach how the viscosity of HPMC may be varied.
Moreover, the viscosity teaching in Bhowmick, in combination with the fact
that Aqualon teaches that one can mix the three types of CM Cs and obtain
differing viscosities, is insufficient to establish a reason one of ordinary skill
in the art would have done so in the context of the Bhowmick composition.
Bhowmick does not teach the viscosity of CMC is critical nor directs one of
ordinary skill in the art to the fact that combinations of CMC are beneficial
or could be successfully employed. We find that the Examiner's conclusion
of obviousness of these claims is based on an impermissible obvious to try
standard. See, e.g., In re Kubin, 561 F.3d 1351, 1359 (Fed. Cir. 2009)
(improper application of obvious to try where "the prior art gave either no
indication of which parameters were critical or no direction as to which of
many possible choices is likely to be successful").
For the reasons discussed above, we reverse the Examiner's rejection
of claims 5, 14, and 24 as being obvious over Bhowmick and Aqualon.
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Claims 15 and 25, 26, 28, 29
The Examiner relies on Rowe for the obviousness of using sodium
citrate dihydrate in the ophthalmologic composition of Bhowmick.
Appellants' argument as to why the Examiner's rejection of claims 15, 25,
26, 28, and 29 is erroneous relies primarily on the arguments made with
respect to claims 1 and 9 (Appeal Br. 32-34), which as discussed above, we
do not find persuasive.
In addition, Appellants argue that Bhowmick does not teach a
formulation with sodium citrate dihydrate or sodium chloride. (Appeal Br.
32.) However, as the Examiner explained, Bhowmick does teach that the
compositions can include osmogents like sodium chloride and demonstrates
a composition that includes 0.7% NaCl. (Non-Final 12 (citing Bhowmick at
Example 1)). Appellants do not contest the Examiner's finding in this
regard. In light of Bhowmick' s teaching, we conclude that inclusion of such
an osmogent in a composition that includes ketorolac and CMC would have
been obvious to one of ordinary skill in the art. Moreover, the Examiner
relies on Rowe for the obviousness of including sodium citrate dihydrate,
and Appellants concede that Rowe teaches citrate dihydrate (Appeal Br. 32).
"Non-obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references .... [The reference] must be read, not in isolation, but for what it
fairly teaches in combination with the prior art as a whole." In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellants also argue that Bhowmick does not teach its formulation
for treating ocular pain and inflammation. We do not find this argument
persuasive because the compositional elements of claim 25 are rendered
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obvious by the combination Bhowmick and Rowe for the reasons discussed
above. And, as discussed above in the claim construction section, the
"wherein" clause of claim 29 is not given patentable weight because it does
not recite any further structural limitation to the elements of the
composition. Because the claimed components are obvious, one of ordinary
skill in the art would expect the composition to be able to be used to treat
pam. Spada, 911 F.2d at 709.
Appellants argue that none of the references teach incorporation of
sodium hydroxide and hydrochloric acid as required by claim 28. (Appeal
Br. 34.) However, as the Examiner explained, Bhowmick teaches that
sodium hydroxide and HCl are known pH adjusters to attain a pH of about
5.0 to 8.0 (Non-Final 12), which Appellants do not dispute. We conclude
the evidence of record establishes that it would have been obvious to include
those well-known compounds in the ophthalmologic composition of
Bhowmick with a reasonable expectation of success in order to maintain the
pH of the composition.
For the reasons discussed above, Appellants do not persuade us that
the Examiner erred in rejecting claims 15, 25, 26, 28, and 29 as being
obvious over Bhowmick, Aqualon, and Rowe. 15
15 In affirming a multiple-reference rejection under 35 U.S.C. § 103, the
Board may rely on fewer than all of the references relied on by the Examiner
in an obviousness rationale without designating it as a new ground of
rejection. In re Bush, 296 F.2d 491,496 (CCPA 1961). As to these claims,
the Examiner does not need to rely on any disclosure of Aqualon regarding
the CMC limitation.
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Claim 27
Appellants' argument as to why the Examiner's rejection of claim 27
is erroneous relies on the arguments made with respect to claims 1 and 9.
(Appeal Br. 33.) We note that claim 27, like claim 5, requires 0.325% w/v
medium viscosity carboxymethyl cellulose and 0.175% w/v high viscosity
carboxymethyl cellulose. We do not find the Examiner has made out a
prima facie case of obviousness as to the requirement of HCMC and MCMC
in the claimed amount, as discussed above with respect to claim 5.
Consequently, we reverse the Examiner's rejection of claim 27 as being
obvious over Bhowmick, Aqualon, and Rowe.
Obviousness: Gusler
Claim 1
The Examiner explains that Ousler teaches a composition that
includes ketorolac tromethamine and a tear substitute. (Non-Final 16.) The
Examiner explains that Ousler teaches an effective amount of ketorolac in
the composition is from about 0.05 to about .5%. (Id.) The Examiner notes
that Ousler exemplifies a combination of ACULAR, which contains 0.5%
ketorolac tromethamine together, with REFRESH, which is known to
contain 0.5% CMC. (Id.) The Examiner also finds that Ousler teaches the
composition can comprise conventional buffers, pH adjusters, and tonicity
agents such as sodium chloride, citric acid, potassium citrate, and
hydrochloric acid and/or sodium hydroxide. (Id. at 17.) The Examiner notes
that like Vehige and Bhowmick, Ousler does not specifically teach the
composition having the claimed values of ketorolac and CMC. (Id.)
However, as with the rejection of the claims over Vehige and Bhowmick,
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the Examiner finds that it would have been obvious to optimize the amounts
of these ingredients with a reasonable expectation of success. (Id.)
Appellants note that the combination of ACULAR and REFRESH
results in a composition that includes 0.25% w/v ketorolac and 0.25% w/v
CMC, and that such a "formulation was less successful in reducing ocular
discomfort comfort 40 minutes post instillation as compared to 0.5% w/v
ACULAR® but provided more comfort immediately after instillation than
0.5% w/v ACULAR®." (Appeal Br. 35.) In light of this, Appellants argue
that "it is unclear why one of ordinary skill in the art would have been
motivated to combine ketorolac and CMC when 0.5% w/[ v] ketorolac
ACULAR® worked much better." (Id.) Appellants further argue that Ousler
does not teach the claimed composition with the claimed amounts of
ketorolac and CMC and the claimed composition "is not suitable for the
treatment of dry eye, which is the goal of the formulations of Ousler." (Id.)
We do not find Appellants' arguments persuasive. That Ousler
teaches 0.25% w/v ketorolac in REFRESH was less successful in reducing
ocular discomfort than 0.5% ketorolac with no REFRESH (Ousler ,r 69)
does not establish Ousler would discourage one from modifying the
ketorolac solution to less than 0.5% or from including a carboxymethyl
cellulose component for the reasons that follow. Ousler specifically
indicates that both 0.5% and 0.25% ketorolac were effective for treating dry
eye, noting that 0.25% ketorolac diluted with REFRESH artificial tears,
though less effective than the 0.5% solution, was, nevertheless, more
comfortable to the patient following instillation. (Ousler ,r,r 64, 69-70.)
Ousler notes that eye drops containing an analgesic and a tear substitute like
REFRESH are much more comfortable to a patient than in the absence of a
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tear substitute like REFRESH. (Ousler ,r 70.) Ousler specifically suggests
one skilled in the art perform dosage range testing to identify an effective
amount of ketorolac less than 0.5% but greater than 0.25%. (Ousler ,r,r 69--
7 0 ("It can be expected that further dose range testing can identify a
concentration higher than 0.25% but less than 0.5% which is more
comfortable than 0.5% but is more efficacious than 0.25%.").) Ousler does
not teach or suggest that carboxymethyl cellulose contributes to the 0.25%
formulation being less efficacious than that of the 0.5%, but rather, that the
lower dose of ketorolac is the contributing factor to the less efficacious
effect. Thus, Ousler provides one of ordinary skill in the art with motivation
to include CMC in a ketorolac tromethamine composition to treat dry eye
and to modify the 0.25% ketorolac-REFRESH composition to increase the
ketorolac above 0.25% but below 0.5%.
We disagree with Appellants' attorney argument that a composition
that contained 0.45% ketorolac tromethamine with CMC would not be
suitable to treat dry eye. That argument is not supported by any record
evidence. "Attorney argument is not evidence." Icon Health & Fitness v.
Strava, 849 F.3d 1034, 1043 (Fed. Cir. 2017). And in contrast to the
attorney argument, we note that Ousler teaches that "[t]he effective amount
of NSAID present in the formulations should be sufficient to create an
analgesic effect," while also being sufficient to reduce discomfort from dry
eye and/or ocular irritation, although preferably it should "not create an
anesthetic effect." (Ousler ,r 25). As discussed above, Ousler teaches that
0.5% ketorolac tromethamine treats dry eye, as does a composition of .25%
ketorolac tromethamine plus 0.5% CMC, and indicates that the ketorolac
amount should provide for an analgesic effect, while the CMC provides for
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patient comfort. And, as discussed above, Ousler teaches dose ranging
testing to identify an effective amount of ketorolac less than 0.5% but
greater than 0.25%. In light of these teachings, we conclude that one of
ordinary skill in the art would have had a reasonable expectation of arriving
at a composition that includes 0.45% ketorolac tromethamine and 0.5%
CMC that would be suitable for treating dry eye.
Furthermore, we do not find the preamble of claim 1, as to the
intended use of the composition, to be limiting. Even if the result of treating
ocular pain and inflammation following cataract surgery were limiting, we
note that claim 1 does not require further compositional elements beyond
0.45% ketorolac tromethamine and about 0.5% CMC so as to achieve a
composition for treating ocular pain and inflammation. Because the
compositional elements of claim 1 in the claimed amounts are rendered
obvious by Ousler, one of ordinary skill in the art would expect the
functional requirement of treating pain and inflammation of claim 1 to be
achieved as well. Spada, 911 F.2d at 709.
For the reasons discussed above, Appellants do not persuade us that
the Examiner erred in rejecting claims 1 as being obvious over Ousler.
We note that Appellants do not argue they have provided unexpected
results over Ousler. However, even if such an argument were to have been
made because the comparison of the claimed invention was to ACULAR
(containing 0.5% w/v ketorolac) and ACULAR LS (containing 0.4% w/v
ketorolac) neither of which contain CMC, we would not find such an
argument persuasive. That is because, as discussed above, the comparison is
not against the closest prior art. In re Baxter Travenol Labs., 952 F.2d at
392.
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Claims 3, 9, 11, and 12, have not been argued separately (Appeal Br.
37-39) and therefore fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
Claim 4
Appellants argue that Ousler does not mention sodium citrate
dihydrate and thus the claim is patentable over Ousler. (Appeal Br. 37 .)
This argument is not persuasive because claim 4 requires "at least one
ingredient selected from the group consisting of sodium chloride, sodium
citrate dihydrate, sodium hydroxide, hydrochloric acid and water."
Appellants do not contest that Ousler teaches a composition that can include
at least one other ingredient from this list other than sodium citrate
dihydrate, such as sodium chloride to adjust tonicity and hydrochloric acid
and/or sodium hydroxide to maintain pH. The example of Ousler combines
Acular® and REFRESH tears together, and it is well known that Acular
includes sodium chloride, and hydrochloric acid and/or sodium hydroxide to
adjust the pH as the Examiner noted (Non-Final 16), which Appellants do
not dispute.
Appellants also argue that it is unclear what formulation of REFRESH
is being referred to in Ousler. (Appeal Br. 37.) We do not find this
argument persuasive for the reasons noted by the Examiner in the Answer
(Ans. 55-56 ("the Examiner had provided an evidentiary product insert for
REFRESH TEARS from 2004 demonstrating that the commercial product is
known to contain 0.5% CMC"), to which Appellants do not respond (see
Reply Br. 4---6).
Consequently, Appellants do not persuade us that the Examiner erred
in rejecting claim 4 as being obvious over Ousler.
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Claims 2, 6-8, 10, 13, and 16-19
Appellants argue that claims 2, 6-8, 10, 13, and 16-19 are inventive
over Ousler because Ousler does not teach or suggest the composition of
claim 1 has the claimed properties (increased bioavailability of ketorolac
( claims 2, 6, 10, 19), reduced ocular pain and inflammation following
cataract surgery ( claim 7, 8, 13, 16), reduced ocular pain and inflammation
and less hyperemia ( claim 17), reduced ocular pain and inflammation and
less ocular burning and stinging (claim 18)). (Appeal Br. 36-41.) We do
not find Appellants' argument persuasive. For the reasons discussed above,
we agree with the Examiner that the composition of claim 1 is obvious from
the teachings of Ousler and Appellants have not established unexpected
results. None of claims 2, 6-8, 10, 13, and 16-19 require further
compositional elements beyond that required by claim 1, so as to achieve the
claimed properties. As explained in the claim construction section above,
we determine that the "wherein" clauses of these claims are not entitled to
patentable weight. Because the compositional elements of claims 2, 6-8, 10,
13, and 16-19 are rendered obvious by Ousler, one of ordinary skill in the
art would expect the functional requirement of claims 2, 6-8, 10, 13, and
16-19 to be achieved as well. Spada, 911 F.2d at 709.
Consequently, for the reasons discussed above, Appellants do not
persuade us that the Examiner erred in rejecting claims 2, 6-8, 10, 13, and
16-19 as being obvious over Ousler.
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Obviousness: Gusler and additional references
Claims 5, 14, and 24
The Examiner recognizes that Ousler does not teach incorporation of a
mixture of MCMC and HCMC in the CMC component of the combined
NSAID with CMC. (Non-Final 18.) The Examiner, however, determines
that such would have been obvious in light of the teachings of Chang. (Id.)
In particular, the Examiner explains that Chang teaches a mixture of
different weights of a polyanionic component such as HCMC and MCMC
that provides better lubrication to the eye and is useful for dry eye. (Id.)
Appellants argue the claimed amounts ofHCMC and MCMC are not
taught by Chang and nothing suggests this ratio in Ousler and Chang
because neither teaches the specific amounts. (Appeal Br. 44.) We do not
find this argument persuasive.
We agree with the Examiner's findings concerning Chang and
conclusion of obviousness. Chang is concerned with providing "relatively
long lasting effective eye lubrication" so as to reduce the frequency of
administration to the eye but not have an unduly disruptive composition
regarding clear vision. (Chang 1 :53---65.) Chang teaches HCMC in
combination with MCMC provides this result and that the concentrations of
each can be varied while still achieving such a result. (Chang 9--10.) Chang
teaches the compositions achieve reduced blurriness and improved ability to
adhere to an eye (a function known for HCMCs (Chang 1:40-41)) compared
to a composition that only contains one polyanionic component in an
equivalent amount to the two different viscosity components of Chang.
(Chang 9.) While Chang exemplifies a combined concentration of these
components of 1 %, Chang also teaches that each component can be present
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in at least 0.1 %, and the range in which the two polyanionic components can
be present to achieve the results is between 0.2 % and 5%. (Chang 5:50-
53.) In light of the foregoing teachings, we agree with the Examiner that it
would have been obvious to use an HCMC and MCMC in the obvious
ketorolac CMC composition suggested by Ousler and modify the amounts of
each of the HCMC and MCMC so as to optimize them along with the
ketorolac tromethamine amount. (Non-Final 18.) Chang provides a reason
to modify the Ousler 0.25% ketorolac-REFRESH composition with a two
component carboxymethylcellulose composition, i.e., to achieve reduced
blurriness and improved ability to adhere to an eye, and to increase the
amount of CMC to above 0.25% (the amount that would be present in
combining ACULAR with REFRESH taught by Ousler), i.e., to obtain a
therapeutic composition that has long lasting effective eye lubrication and
which would result in reduced frequency of administration to the eye but not
have an unduly disruptive composition regarding clear vision.
We agree with the Examiner that there would have been a reasonable
expectation of success in arriving at the claimed amounts of HCMC and
MCMC. (Id.) Appellants have not established that the art teaches away
from the claimed percentage of ketorolac tromethamine or HCMC and
MCMC or that they have established unexpected results of the claimed
invention. Thus, Appellants do not persuade us that the Examiner erred in
rejecting claim 5 for obviousness over Ousler and Chang.
Claims 14 and 24 have not been argued separately (Appeal Br. 44--45)
and therefore fall with claim 5. 37 C.F.R. § 4I.37(c)(l)(iv).
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Claim 15
The Examiner notes that Ousler teaches inclusion of buffers such as
citric acid and potassium citrate, although it does not expressly teach
incorporation of sodium citrate. (Non-Final 19.) The Examiner explains
that Harting "teaches that sodium borate, boric acid, trisodium citrate ( also
known as sodium citrate dihydrate) are all known functionally equivalent
ophthalmic buffers (Col. 3 line3-7)" and that it would have been obvious to
one of ordinary skill in the art to have substituted trisodium citrate in the
Ousler composition with a reasonable expectation of success. (Id.)
Appellants argue that they "have gone into great detail in the previous
rejection as to why claim 9 is non-obvious over Ousler" and that while
Harting teaches compounds for lowering intraocular pressure and describes a
number of buffers including mono, di- and trisodium citrate, "Harting adds
nothing to Ousler in obviating claim 15." (Appeal Br. 45.) 16 This is not
deemed to be a separate argument for patentability of claim 15, see, e.g.,
Lovin, 652 F.3d at 1357, and claim 15 falls with claim 9.
Claims 25, 26, 28, and 29
The Examiner explained that ACULAR, which Ousler teaches in
combination with REFRESH, includes sodium chloride as a tonicity agent.
16 Appellants appear to argue that Harting does not teach sodium citrate
dehydrate, but does not explain why trisodium citrate taught by Harting is
not "also known as sodium citrate dihydrate," as the Examiner asserted. We
agree with the Examiner that Harting teaches the claimed sodium citrate
dihydrate by its disclosure of "mom-, di- or trisodium citrate" (Harting 3 :3-
7).
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Application 13/446,870
(Non-Final 16.) The Examiner relies on the teachings of Si for the
obviousness of the use of sodium chloride value claimed. (Id. at 20.)
Appellants argue that Si is concerned with an "entirely different
composition" and "would do very little to guide one of ordinary skill in the
art to the sodium chloride concentrations desired osmolality of applicants
claimed invention." (Appeal Br. 46.) We do not find this argument
persuasive. Si is directed to a composition to be instilled in the eye (Si
3:40-48), just as Ousler is, regardless of the fact that the active ingredient of
the two are different. Si is thus analogous art because it is in the same field
of endeavor as Ousler. Moreover, it is also reasonably pertinent to the
particular problem with which the inventor is involved: a topical ophthalmic
composition. See, e.g., In re Clay, 966 F.2d 656, 658-59 (Fed. Cir. 1992).
Thus, the discussion of osmotic pressure of the composition and the
ingredients that may be used and the concentrations ranges for use are
deemed applicable to Ousler's topical ophthalmic formulation.
Moreover, even though Si does not specifically teach the precise
amount of NaCl claimed, we agree with the Examiner that it would have
been routine optimization to arrive at the claimed 0.7% of NaCl. As noted
above, the normal desire of artisans to improve upon what is already
generally known is motivation to optimize variables. See Peterson, 315 F .3d
at 1330. Appellants have not provided sufficient evidence of unexpected
results regarding the claimed components for the reasons discussed above.
Claims 26 and 28 have not been argued separately, (see, e.g., Lovin,
652 F.3d at 1357 (explaining that separately arguing a claim requires more
substantive arguments in an appeal brief than a mere recitation of the claim
elements and a naked assertion that the corresponding elements were not
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Application 13/446,870
found in the prior art"), and therefore fall with claim 25. 37 C.F.R.
§ 4I.37(c)(l)(iv).
Appellants argue that the Examiner does not explain why claim 29
would have been obvious and that there is no teaching or suggestion in the
combination of references of a composition used for treating pain and
inflammation following cataract surgery. (Appeal Br. 47--48.) We do not
find this argument persuasive because the compositional elements of claim
29 are rendered obvious by the combination of Ousler, Harting, and Si for
the reasons discussed above. And, as discussed above in the claim
construction section, the "wherein" clause of claim 29 is not given
patentable weight because it does not recite any further structural limitation
to the elements of the composition. Because the claimed components are
obvious, one of ordinary skill in the art would expect the composition to be
able to be used to treat pain. Spada, 911 F.2d at 709. That is especially true
in light of Ousler's teaching that the effective amount ofNSAID should
achieve an analgesic effect.
For the reasons discussed above, Appellants do not persuade us that
the Examiner erred in rejecting claims 25, 26, 28, and 29 as being obvious
over Ousler, Harting, and Si.
Claim 27
Regarding the specifically claimed amounts ofHCMC and MCMC
required by claim 2 7, Appellants' arguments are the same as those set forth
for claim 5 discussed above. (Compare Appeal Br. 48, with Appeal Br. 44.)
We do not find Appellants' arguments persuasive for the reasons we
discussed above regarding claim 5.
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Appeal2017-002519
Application 13/446,870
For the reasons discussed above, Appellants do not persuade us that
the Examiner erred in rejecting claim 27 as being obvious over Ousler,
Chang, Harting, and Si.
Non-Statutory Obviousness-Type Double Patenting
Application Nos. 12/953,622; 13/081,161; and 13/446,891 have been
abandoned by Appellants. The rejections made by the Examiner on the
ground of non-statutory double patenting relying on those applications are
therefore moot.
Appellants have not substantively argued the propriety of the non-
statutory double patenting rejections made by the Examiner relying on U.S.
Patent Nos. 7,842,714; 8,512,717; 8,992,952; 9,192,571; or Application No.
13/640,033. (See Appeal Br. 49--51.) Consequently, we summarily affirm
the Examiner's non-statutory double patenting rejections relying on those
patents and patent application.
SUMMARY
We affirm the Examiner's rejection of claims 9, 10, 12, 14, 17, and 18
under pre-AIA 35 U.S.C. 103(a) as unpatentable over Vehige.
We affirm the Examiner's rejection of claims 1-8, 11, 13, 16, 19, and
21-24 under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Vehige and
Chemg-Chyi.
We affirm the Examiner's rejection of claim 15 under pre-AIA 35
U.S.C. § 103(a) as unpatentable over Vehige, Chemg-Chyi, and Rowe.
We affirm the Examiner's rejection of claims 25-29 under pre-AIA
35 U.S.C. § 103(a) as unpatentable over Vehige, Chemg-Chyi, Rowe and Si.
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Application 13/446,870
We affirm the Examiner's rejection of claims 1--4, 6-13, and 16-19
under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Bhowmick.
We reverse the Examiner's rejection of claims 5, 14, and 24 under
pre-AIA 35 U.S.C. § 103(a) as unpatentable over Bhowmick and Aqualon.
We affirm the Examiner's rejection of claims 15 and 25-29 under pre-
AIA 35 U.S.C. § 103(a) as unpatentable over Bhowmick, Aqualon, and
Rowe.
We affirm the Examiner's rejection of claims 1--4, 6-13, and 16-19
under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Ousler.
We affirm the Examiner's rejection of claims 5, 14, and 24 under pre-
AIA 35 U.S.C. § 103(a) as unpatentable over Ousler and Chang.
We affirm the Examiner's rejection of claim 15 under pre-AIA 3 5
U.S.C. § 103(a) as unpatentable over Ousler and Harting.
We affirm the Examiner's rejection of claims 25, 26, 28, and 29 under
pre-AIA 35 U.S.C. § 103(a) as unpatentable over Ousler, Harting, and Si.
We affirm the Examiner's rejection of claim 27 under pre-AIA 35
U.S.C. § 103(a) as unpatentable over Ousler, Harting, Si, and Chang.
We affirm the Examiner's rejection of claims 1-19 and 21-29 on the
ground of non-statutory obviousness-type double patenting as being
unpatentable over claims 1-3 of US Patent No. 7,842,714.
WeaffirmtheExaminer'srejectionofclaims9, 10, 12, 14, 17,and 18
on the ground of non-statutory obviousness-type double patenting as being
unpatentable over claims 1-6 of US Patent No. 8,512,717.
We affirm the Examiner's rejection of claims 1-9 and 21-24 on the
ground of non-statutory obviousness-type double patenting as being
unpatentable over claims 1-10 of US Patent No. 8,992,952.
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Appeal2017-002519
Application 13/446,870
We affirm the Examiner's rejection of claims 1-19 and 21-29 on the
ground of non-statutory obviousness-type double patenting as being
unpatentable over claims of US Patent 9,192,571.
The Examiner's rejection of claims 1-19 and 21-24 on the ground of
non-statutory obviousness-type double patenting as being unpatentable over
claims of Application No. 12/953,622 is moot because that Application has
been abandoned.
The Examiner's rejection of claims 1-19 and 21-24 on the ground of
non-statutory obviousness-type double patenting as being unpatentable over
claims of Application No. 13/081,161 is moot because that Application has
been abandoned.
The Examiner's rejection of claims 1-19 and 21-29 on the ground of
non-statutory obviousness-type double patenting as being unpatentable over
claims of Application No. 13/446,891 is moot because that Application has
been abandoned.
We affirm the Examiner's rejection of claims 1-19 and 21-24 on the
ground of non-statutory obviousness-type double patenting as being
unpatentable over claims 21-24 of copending Application No. 13/640,033.
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
40