Harrow IP, LLC

Patent Trials and Appeals Board

Nov 4, 2021

2020005499 (P.T.A.B. Nov. 4, 2021)

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.
15/061,488 03/04/2016 William F. Wiley 109554-670704-0004-02-06 7750
27148 7590 11/04/2021
POLSINELLI PC
PO Box 140310
KANSAS CITY, MO 64114-0310
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
11/04/2021 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):
patentdocketing@polsinelli.com
rendsley@polsinelli.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte WILLIAM F. WILEY

Appeal 2020-005499
Application 15/061,488
Technology Center 1600
____________

Before ULRIKE W. JENKS, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
directed to a method of treating ophthalmological disease condition or
pathology. Appellant1 requests review2 of Examiner rejections of the claims

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies the real party in interest as Harrow IP,
LLC. Appeal Br. 3.
2 Herein we refer to the Specification filed March 4, 2016 (“Spec.”), Final
Office Action mailed May 23, 2019 (“Final Act.”); Appeal Brief filed March
19, 2020 (“Appeal Br.”); Answer mailed May 22, 2020 (“Ans.”), and Reply
Brief filed July 20, 2020 (“Reply Br.”).
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as being obvious and indefinite. We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Claims 1, 2, 4–6, 10–14, and 16 are on appeal,3 and can be found in
the Claims Appendix of the Appeal Brief. Claim 1 is representative of the
claims on appeal, and reads as follows:
1. A method for treating an ophthalmological disease, condition
or pathology in a mammalian subject in need of such treatment,
the method comprising delivering to the subject a composition
consisting of:
(a) a therapeutic component consisting of:
(a1) a therapeutically effective quantity of an anti-
bacterial agent independently selected from the group
consisting of quinolone, a fluorinated quinolone and
pharmaceutically acceptable salts, hydrates, solvates or
N-oxides thereof; and
(a2) a therapeutically effective quantity of a
corticosteroid independently selected from the group
consisting of prednisone, prednisolone,
methylprednisone, corticol, cortisone, fluorocortisone,
deoxycorticosterone acetate, aldosterone, budesonide,
derivatives or analogs thereof and pharmaceutically
acceptable salts, hydrates, solvates, ethers, esters, acetals
and ketals thereof;
(b) a pharmaceutically acceptable solubilizing and suspending
agent selected from the group consisting of non-ionic

3 Appellant identifies Appeal No. 2020-005444 (U.S. Serial No. 15/148,574)
as related. Appeal Br. 4. We note that the following appeals are also related:
Appeal No. 2020-005442 (U.S. Serial No. 15/057,711) and Appeal No.
2020-005812 (U.S. Serial No. 14/972,822).
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polyoxyethylene-polyoxypropylene block copolymers and
polysorbate; and
(c) a pharmaceutically acceptable carrier consisting of edetate
calcium disodium, hydrochloric acid and sterile water or any
combination thereof,
wherein the composition loses no potency and maintains
stability after about 6 months of storage,
wherein the method of delivery is selected from the
group consisting of intravitreal injection, intraocular
intracameral injection, intra-lesional injection, intra-articular
injection, subconjunctival injection, and sub-tenon injection,
wherein the method is performed without using pre- or
post-operative topical ophthalmic drops,
wherein the composition is delivered in the course of
intraocular surgery performed for treating an ophthalmological
disease, condition or pathology selected from the group
consisting of cataracts, retinal disease, glaucoma disease,
planned vitreoctomy, and traumatic ocular penetration,
thereby treating the ophthalmological disease, condition
or pathology.
Appeal Br. 33–34 (Claims Appendix). The other independent claims,
claims 4, 13, and 16, recite the use of the same therapeutic component
using different application steps.

REJECTIONS
Appellant requests review of the following grounds of rejection made
by Examiner:
I. Claims 1, 10, 11, and 13 under 35 U.S.C. § 103 as obvious over
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Cagle4 in view of John,5 Scott,6 Abelson,7 and Peyman;8
II. Claims 4–6 and 12 under 35 U.S.C. § 103 as obvious over
Cagle in view of John, Campos,9 Peyman and Scott;
III. Claims 2 and 14 under 35 U.S.C. § 103 as obvious over Cagle
in view of John, Scott, Abelson, and Peyman;
IV. Claim 16 under 35 U.S.C. § 103 as obvious over Cagle in view
of John, Scott, and Abelson; and
V. Claims 1, 4, 13, and 16 as being indefinite under 35 U.S.C.
§ 112(b).

I. Obviousness over Cagle, John, Scott, Abelson, and Peyman
The issue is whether the preponderance of the evidence of record
supports Examiner’s conclusion that the combination of references renders
the claimed method obvious.
A. Findings of Fact (FF)
FF1. Cagle teaches that ophthalmic surgical procedures that create “a
risk of microbial infections frequently also cause inflammation
of the affected tissues.” Cagle ¶ 5. Thus, it would be convenient

4 Cagle et al. US 2002/0193370 A1, published Dec. 19, 2002 (“Cagle”).
5 Biju John, Intravitreal Injections, XIX OCULAR PHARMACOLOGY, 46–57
(2007).
6 Scott, US 2009/0092574 A1, published Apr. 9, 2009.
7 Abelson, US 2006/0183698 A1, published Aug. 17, 2006.
8 Peyman, US 6,395,294 Bl, issued May 28, 2002.
9 Mauro Campos et al., Efficacy and tolerability of a fixed-dose moxifloxacin
— dexamethasone formulation for topical prophylaxis in LASIK: a
comparative, double-masked clinical trial, 2 CLIN OPHTHALMOL. 331–338
(2008) (“Campos”).
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to have compositions “that combine the anti-infective activity
of one or more antibiotics with the anti-inflammatory activity of
one or more steroid or non-steroid agents in a single
composition.” Id. In addition to prophylactically treating
patients after surgical procedures, other ophthalmic conditions
such as “conjunctivitis, keratitis, blepharitis, dacyrocystitis,
hordeolum and corneal ulcers” can also be treated with the
composition. Id. ¶ 8. The ophthalmic compositions are
“typically administered to the affected ophthalmic . . . tissues
by topically applying one to four drops of a sterile solution or
suspension.” Id. ¶ 38, see also id. ¶ 10 (“The compositions are
preferably sterile, and have physical properties (e.g., osmolality
and pH) that are specially suited for application to ophthalmic,
otic and nasal tissues, including tissues that have been
compromised as the result of preexisting disease, trauma,
surgery or other physical conditions.”).
FF2. Cagle teaches that “[t]he [antibiotic] compound Moxifloxacin is
most preferred.” Cagle ¶ 27. The composition will contain
moxifloxacin “in a concentration of from about 0.1 to about
1.0 percent by weight (“wt. %”) of the compositions.” Id. ¶ 31.
FF3. Cagle teaches that the composition may contain one or more
anti-inflammatory agents. The anti-inflammatory agents “are
broadly classified as steroidal and non-steroidal” agents. Cagle
¶ 32. The composition “will typically contain one or more anti-
inflammatory agents in an amount of from about 0.01 to about
1.0 wt. %.” Id. ¶ 37.
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FF4. Cagle teaches that the steroidal anti-inflammatory agents
include “glucocorticoid is selected from the group consisting of
dexamethasone, rimexolone, prednisolone, fluorometholone,
hydrocortisone, mometasone, fluticasone, beclomethasone,
flunisolide, triamcinolone and budesonide.” Cagle, claim 4.
FF5. Cagle teaches that “[t]he preferred non-steroidal anti-
inflammatory agents are: prostaglandin H synthetase inhibitors
(Cox I or Cox II), also referred to as cyclooxygenase type I and
type II inhibitors, such as diclofenac, flurbiprofen, ketorolac,
. . . naproxen, ibuprofen, bromfenac, ketoprofen,
meclofenamate, piroxicam, sulindac, mefanamic acid,
diflusinal, oxaprozin, tolmetin,” among others. Cagle ¶ 36.
FF6. Cagle teaches that the composition has a pH range between
4.5–8 and osmotic values in the range of 200 to about 400
milliosmoles per kilogram of water, and preferably about
300 mOsm/kg. Cagle ¶ 39.
FF7. Cagle teaches incorporating suitable preservatives into
multidose containers at a concentration of 0.001% to 1.0% by
weight. Cagle ¶ 40. “Suitable preservatives include:
polyquatemium-1, benzalkonium chloride, thimerosal,
chlorobutanol, methyl paraben, propyl paraben, phenylethyl
alcohol, edetate disodium, sorbic acid, or other agents known to
those skilled in the art.” Id.
FF8. Cagle teaches that the solubility of the composition may be
enhanced with the inclusion of 0.01% to 2% by weight of a
co-solvent. Cagle ¶ 41. “[C]o-solvents include polysorbate 20,
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60, and 80, polyoxyethylene/polyoxypropylene surfactants
(e.g., Pluronic F-68, F-84 and P-103), cyclodextrin, or other
agents known to those skilled in the art.” Id.
FF9. John teaches that “[i]ntravitreal injections have provided the
logical method to the VR surgeons to bypass the blood retinal
barrier so as to provide clinically effective doses of therapeutic
agents to the target tissue.” John 46. “This is the only route of
administration by which antimicrobial agents can be made to
neatly bypass the blood retinal barrier and achieve therapeutic
concentrations in the vitreous.” John 46. John teaches that
“[s]hort acting steroids like Dexamethasone is currently given
along with antibiotics in the treatment of Bacterial
Endophthalmitis.” Id. at 48.
FF10. Scott teaches ophthalmic compositions containing of facially
amphiphilic antimicrobial polymers and oligomers and their
uses. Scott, Abstract. Scott teaches including preservatives such
as disodium EDTA. Scott ¶ 772.
Optionally one or more stabilizers can be included
in the compositions of the invention to enhance chemical
stability where required. Suitable stabilizers include, but
are not limited to, chelating agents or complexing agents,
such as, for example, the calcium complexing agent
ethylene diamine tetraacetic acid (EDTA). For example,
an appropriate amount of EDTA or a salt thereof, e.g.,
the disodium salt, can be included in the composition to
complex excess calcium ions and prevent gel formation
during storage. EDTA or a salt thereof can suitably be
included in an amount of about 0.01 % to about 0.5%. In
those embodiments containing a preservative other than
EDTA, the EDTA or a salt thereof, more particularly
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disodium EDTA, can be present in an amount of about
0.025% to about 0.1 % by weight.
Scott ¶ 774.
FF11. Ableson teaches formulation “comprising a therapeutically-
effective amount of an ophthalmically-active antimicrobial
agent, and an ophthalmically-active anti-inflammatory or
steroidal agent.” Abelson, Abstract. Ableson teaches
immunosuppressive agents such as dexamethasone and
prednisolone. Id. ¶ 11. Ableson teaches treating diseases that
“include, for example, meibomianitis, blepharitis conjunctival
hyperemia, eyelid hyperemia, keratitis and ocular rosacea.” Id.
¶ 17. Abelson teaches topical formulation that include
antimicrobial such as fluoroquinolone in conjunction with an
anti-inflammatory agent such as prednisolone. Id. ¶ 25. Ableson
teaches that the formulations can be made into dosage forms for
injections, eye drops, gels or ointments, but notes that topical
applications are preferable. Id. ¶ 48.
FF12. Peyman teaches the “of one or more vitreous delineating agents
to improve visualization of the vitreous during surgery to
alleviate a structural disorder of an eye.” Peyman 3:11–13.
Peyman teaches that such agents include anti-inflammatory
agents as well as anti-microbial agents as long as they are
visible during surgery. See id. at 3:35–42. Peyman teaches that
“[t]he intravitreal concentration of dexamethasone [a
corticosteroid] may be higher when administered periocularly
than orally.” Id. at 4:7–8. Corticosteroid “use for the control of
postoperative inflammation and control of proliferative
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vitreoretinopathy following vitrectomy is well documented.” Id.
at 4:32–34. Peyman notes that other corticosteroids can also be
used including “prednisolone acetate (Econopred™ and others),
prednisolone sodium phosphate (Hydeltrasol™ and others),
prednisolone tebutate (Hydeltra-T.B.A.™ and others).” Id. at
5:32–35.
B. Analysis
1. Claim 1
Examiner finds that Cagle teaches ophthalmic compositions
containing the corticosteroid prednisolone and moxifloxacin. Final Act. 5;
FF1, FF4. Examiner finds that the composition of Cagle can be administered
as eye drops and that such compositions can contain water and are sterile.
Final Act. 5; FF1, FF6; Cagle ¶¶ 44–45. Examiner finds that Cagle teaches
using the composition “for treating an ophthalmological disease, condition
or pathology given it treats ophthalmic infections.” Final Act. 5; FF1.
Examiner acknowledges that Cagle does not disclose intravitreal injections.
Final Act. 6.
Examiner relies on John for teaching intravitreal injections and the
benefit of supplying a composition via injection. See Final Act. 6; FF9.
Examiner finds that “intravitreal injections bypass the blood retinal barrier
and thus can provide effective dosages of the active agents to the target
tissue thus therapeutic intraocular concentrations of the drug can be achieved
immediately and effectively without systemic absorption and toxicity.” Final
Act. 6. Examiner concludes that “[t]here would have been a reasonable
expectation of success given intravitreal injection is an art recognized
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ophthalmological mode of administration and has been performed with
antibiotics and corticosteroids.” Id.
Examiner finds that Cagle teaches supplying the compositions after
surgical procedures but “does not expressly teach methods of treating
diseases or conditions during intraocular surgery selected from cataracts,
retinal disease, glaucoma disease, planned vitreoctomy, or traumatic ocular
penetration.” Final Act. 7. Examiner relies on Ableson and Peyman for
teaching treating “ocular conditions including but not limited to keratitis,
glaucoma and ocular penetration” (id.) as well supplying the composition
while performing the procedures. Id. at 8.
Examiner concludes that based on the combined teaching of the
references it would have been obvious to one of ordinary skill in the art at
the time the invention was made “to administer the composition of the
modified Cagle during surgery to not only prevent ophthalmic infection but
to allow visualization of the eye as the corticosteroids are known to be
[useful as] a visual indicator during surgical procedures.” Final Act. 8.
Upon consideration of the evidence on this record, and each of
Appellant’s contentions, we find that the preponderance of evidence
supports Examiner’s conclusion that the subject matter of Appellant’s claims
is unpatentable. Accordingly, we affirm Examiner’s rejections for the
reasons set forth in the Answer and Final Office Action. We address
Appellant’s contentions below.
(a) Preservatives
Claim 1 is directed to a method of treating an ophthalmic disease by
delivering a composition consisting of a fluorinated quinolone, such as
moxifloxin, a corticosteroid, a solubilizing agent, and a pharmaceutically
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acceptable carrier. The claim further requires that the “pharmaceutically
acceptable carrier consisting of edetate calcium disodium,[10] hydrochloric
acid and sterile water or any combination thereof.” We find that the
limitation “any combination thereof” as recited in claim element 1(c) is
reasonably interpreted to include a carrier composition that does not contain
edetate calcium disodium.
Appellant contends that Cagle teaches that preservatives are required
to prevent microbial contamination. See Appeal Br. 20–21. Specifically
citing Cagle paragraph 40, as disclosing “products” which “renders unclear
whether Cagle intended to require preservatives in its compositions or that
the commercially available raw materials (i.e., “products”) must necessarily
include preservatives.” Id. at 21, see also id. (“[O]ne of skill in the art in
view of Cagle would understand that when the compositions of Cagle are in

10 We note that Examiner relies on paragraph 774 of Scott for teaching that
calcium EDTA is an alternative to disodium EDTA and functions as a
preservative. Final Act. 6; Ans. 6; FF10. We are not persuaded by
Examiner’s interpretation of Scott. In the Reply Brief Appellant argues that
calcium EDTA is structurally different from disodium EDTA and “submits
that Scott is absolutely silent with regard to ‘calcium EDTA.’ The mere fact
that Scott states that ethylene diamine tetraacetic acid (EDTA) is a ‘calcium
complexing agent’ is not dispositive of Scott reciting that ‘calcium EDTA’ is
a suitable alternative to disodium EDTA.” Reply Br. 2. Appellant presents
this argument for the first time in the Reply Brief. Appellant does not
explain what good cause there might be to consider the new arguments.
Appellant’s new arguments are thus untimely and accordingly, have not
been considered. See Ex parte Borden, 93 USPQ2d 1473 (BPAI 2010)
(informative). As noted above, however, we do not interpret the claim as
requiring calcium disodium EDTA.
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solution form, the solution requires a preservative at a level of from 0.001 %
to 1.0% by weight. (Saadeh11 Declaration at pages 2-3).”).
We are not persuaded by Appellant’s interpretation that Cagle’s
composition necessarily requires preservatives. Paragraph 40 of Cagle reads
as follows:
Ophthalmic, otic and nasal pharmaceutical products are
typically packaged in multidose form. Preservatives are thus
required to prevent microbial contamination during use.
Suitable preservatives include: polyquatemium-1,
benzalkonium chloride, thimerosal, chlorobutanol, methyl
paraben, propyl paraben, phenylethyl alcohol, edetate disodium,
sorbic acid, or other agents known to those skilled in the art.
The use of polyquatemium-1 as the antimicrobial preservative
is preferred. Typically such preservatives are employed at a
level of from 0.001 % to 1.0% by weight.
Cagle ¶ 40.
We determine that a reasonable reading of Cagle’s paragraph 40 is
that when the ophthalmic, otic and nasal compositions, i.e. products, are
packaged as multi-dose forms then a preservative should be included.
However, the paragraph reasonably suggests that when single dose
compositions are contemplated then preservatives are not required.
Accordingly, we are not persuaded by Appellant’s contention that the
combined references necessarily requires the incorporation of preservatives
into the product.

11 Declaration under 37 C.F.R. §1.132 by Dr. Dennis Saadeh submitted July
16, 2018 (“Saadeh Declaration”).
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(b) Long felt need
Appellant contends that there was a long felt and unmet need for
combination therapy. Appellant relies on the Wiley12 Declaration to support
this position. Appeal Br. 22. Appellant contends that “by combining these
medications into a single composition, the claimed invention goes against
conventional wisdom by eliminating the need for a waiting period between
administering each medication.” Id. (citing Wiley Declaration 2–3).
Appellant further relies on the Tyson13 Declaration to establish “that there is
[an] art recognized problem that has existed for a long period of time
without solution, as evidenced by the fact that cataract patients are still
provided with a multitude of disposable vials of the medications and must
instill the correct ones at the correct times.” Id. at 23.
We are not persuaded. Establishing long-felt need requires objective
evidence that an art-recognized problem existed for a long period of time
without solution. In particular, the evidence must show that the need was a
persistent one that was recognized by those of ordinary skill in the art. See In
re Gershon, 372 F.2d 535, 538 (CCPA 1967). The relevance of long-felt
need and the failure of others to the issue of obviousness depends on several
factors. First, the need must have been a persistent one that was recognized
by those of ordinary skill in the art. See Orthopedic Equip. Co. v. All
Orthopedic Appliances, Inc., 707 F.2d 1376, 1382 (Fed. Cir. 1983); see also
In re Gershon, 372 F.2d 535, 538 (CCPA 1967). Second, the long-felt need

12 Declaration under 37 C.F.R. § 1.132 by Dr. William Wiley submitted
July 16, 2018 (“Wiley Declaration”).
13 Declaration under 37 C.F.R. §1.132 by Dr. Sydney L. Tyson, MD, MPH,
submitted February 14, 2019 (“Tyson Declaration”).
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must not have been satisfied by another before the invention by applicant.
See Newell Co. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988)
(“[O]nce another supplied the key element, there was no long-felt need or,
indeed, a problem to be solved . . . .”) Third, the invention must in fact
satisfy the long-felt need. See In re Cavanagh, 436 F.2d 491, 496 (CCPA
1971) (One must also show that the others who failed had knowledge of the
critical prior art.). “[L]ong-felt need is analyzed as of the date of an
articulated identified problem and evidence of efforts to solve that problem.”
Texas Instruments, Inc. v. ITC, 988 F.2d 1165, 1178 (Fed. Cir. 1993).
We agree with Examiner that Appellant’s evidence of long felt need
in the Wiley and Tyson Declarations is unpersuasive because Cagle already
suggests pharmaceutical compositions that encompasses combination
therapies by reciting that the composition can contain “one or more anti-
inflammatory agents” in conjunction with the other elements as recited in the
claim. Final Act. 10; Ans. 8; FF3. In other words, Cagle provides the
instructions for solving the problem of administering antibiotics and anti-
inflammatory agents at the same time. See FF1–FF8.
We are also not persuaded by Appellant’s contention that “[t]he
claimed composition meets a long-felt yet unfulfilled need and goes against
accepted wisdom in the art.” Tyson Declaration 2; Wiley Declaration 4 (“By
combining these medications into [a] single injection that is administered
during the surgical procedure, the claimed invention goes against
conventional wisdom by eliminating the need for post-surgical eye drops.”).
A suggestion that in practice patients still needed to utilize multiple solutions
in separate vials over an extended period of time does not provide factual
evidence that an art-recognized problem existed without solution. Tyson
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Declaration 4. The fact that single formulation combination therapies are not
presently used and are not the standard of care in treating patients is not
evidence that these formulations are not obvious. See Purdue Pharma L.P. v.
Endo Pharmaceuticals Inc., 438 F.3d 1123, 1134 (Fed. Cir. 2006) (“[T]he
quantum of proof necessary for FDA approval is significantly higher than
that required by the PTO.”). Here, Cagle suggests producing a single
composition for providing combination therapy that provides anti-infective
activity of an antibiotic with one or more anti-inflammatory agents. FF1,
FF3. Thus, Cagle supplies the key element of including multiple actives in
one composition.
(c) Injection
Appellant contends that Cagle teaches that the compositions are
formulated for application to ophthalmic, otic, and nasal tissues but “fails to
teach or suggest that Cagle’s compositions can be administered via
injection.” Appeal Br. 23. Appellant contends that there is no teaching or
suggestion for the “use of surfactants, such as polyoxyethlene/
polyoxypropylene (i.e., poloxamer)” for injection into the eye. Id. at 24.
We are not persuaded. We agree with Examiner that Appellant’s
arguments attacking the references individually (see, e.g., Appeal Br. 23–24)
is not persuasive, where the rejection is based on their combination. Ans. 14
(citing In re Keller, 642 F.2d 413, 426 (CCPA 1981)). As Examiner
explains, Cagle teaches combination compositions while Johns was relied
upon for teaching administration by intravitreal injection, and that this route
of administration reduces systemic absorption, toxicity, and provides
immediate therapeutic effect. See Ans. 14.
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We are also not persuaded by Appellant’s contention that the use of
surfactants such as polyoxyethlene/polyoxypropylene (i.e., poloxamer) is not
indicated for injection. This argument is not supported by evidence in the
record. See Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir.
1997) (“[A]rguments of counsel cannot take the place of evidence lacking in
the record.”).
(d) Stable
Appellant contends that the Specification “describes that selecting the
appropriate excipient for use in the pharmaceutical formulations ensures that
the corticosteroid ‘safely forms a stable suspension even when moxifloxacin
is also present in the same formulation.’” Appeal Br. 25 (citing Spec. ¶ 43).
We are not persuaded. Cagle suggests a single composition containing
an anti-infective agent, moxifloxacin, in conjunction with one or more anti-
inflammatory agents in a single composition, and further suggests that the
solubility of the composition can be improved by including a co-solvent. See
FF1–FF4, FF6, FF8. Under the circumstances, including the fact that the
Patent and Trademark Office has no laboratory in which to make
compositions and test their stability, the burden is reasonably shifted to
Appellant to show that the compositions of Cagle as modified do not have
the requisite stability. Compare In re Spada, 911 F.2d 705 (Fed. Cir. 1990),
with In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (where the claimed and
prior art products are identical or substantially identical, or are produced by
identical or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product).
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2. Claims 10, 11, and 13
With respect to these rejections, Appellant relies on the same
arguments relied upon with respect to claim 1, discussed above. See Appeal
Br. 26–27. Thus, for the reasons discussed above, we find that Examiner has
established a prima facie showing of obviousness with respect to claim 1.
Accordingly, we affirm the rejection of claims 10, 11, and 13 as well.
C. Conclusion
We conclude that the preponderance of the evidence of record
supports Examiner’s conclusion that the combination of Cagle, John, Scott,
Abelson, and Peyman renders the composition of claims 1, 10, 11, and 13
obvious. We thus affirm the rejection of claims 1, 10, 11, and 13 under
35 U.S.C. § 103(a) as being obvious.
II. Obviousness over Cagle, John, Campos, Peyman, and Scott
The issue is whether the preponderance of the evidence of record
supports Examiner’s conclusion that the combination of references renders
the claimed method obvious.
A. Findings of Fact (FF)
FF13. Campos teaches applying the therapy in patients that have
undergone Laser-assisted in situ keratomileusis (LASIK).
Campos 1. Campos teaches combination therapy containing
“0.5% moxifloxacin and 0.1 % dexamethasone formulation.”
Campos 1. Campos “tested this combination therapy in a
typical LASIK population and compared its efficacy and
tolerability vs conventional administration of 0.5%
moxifloxacin (Vigamox®, Alcon Laboratories, Inc.) and 0.1 %
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dexamethasone (Maxidex®, Alcon Laboratories, Inc.) from
individual bottles.” Campos 2.
B. Analysis
1. Claim 4
Examiner finds that Cagle teaches an ophthalmic composition
containing an anti-infective agent, moxifloxacin, in conjunction with one or
more anti-inflammatory agents and suggests adding a co-solvent to improve
the solubility of the composition. Final Act. 10; see FF1–FF4, FF6, FF8.
Examiner acknowledges that Cagle does not expressly teach administration
via injection. Final Act. 4. “However, John discloses [that] intravitreal
injections bypass the blood retinal barrier and thus can provide effective
dosages of the active agents to the target tissue thus therapeutic intraocular
concentrations of the drug can be achieved immediately and effectively
without systemic absorption and toxicity.” Final Act. 11; FF9. Examiner
relies on Campos for teaching that a combination of antibiotic and steroid
can be administered after LASIK surgery. FF13. Examiner acknowledges
that neither Cagle nor Campos teaches injecting the formulations during
surgery. Final Act. 12. Examiner looks to the teachings of Peyman for
injecting a corticosteroid and an anti-infective agent during surgery. Final
Act. 12; FF12.
Appellant contends that “one of skill in the art would not have looked
to Abelson for motivation to inject a composition that includes
polyoxyethlene/polyoxypropylene (i.e., poloxamer) into the eye since
Campos is directed to topical applications.” Appeal Br. 28.
We are not persuaded by Appellant’s contention and agree with
Examiner that “that Cagle already teaches that the composition has
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polyoxyethylene-polyoxypropylene (i.e. Pluronic also known as Poloxamer)
as the surfactant present with the corticosteroid and moxifloxacin.” Ans. 14.
(citing In re Keller, 642 F.2d 413, 426 (CCPA 1981)). Examiner relies on
Abelson for teaching a similar composition used for ophthalmic purposes
that can be formulated into various dosage forms including for injection.
Ans. 15; FF11. As Examiner explains, Abelson was not relied upon for
teaching the use of polyoxyethylene-polyoxypropylene surfactants. See Ans.
15.
We are also not persuaded by Appellant’s contention that the use of
surfactants such as polyoxyethlene/polyoxypropylene (i.e., poloxamer) is not
indicated for injection. This argument is not supported by evidence in the
record. See Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir.
1997) (“[A]rguments of counsel cannot take the place of evidence lacking in
the record.”). Cagle teaches that the solubility of the components may be
improved by the use of co-solvents. FF8. Abelson teaches formulating
injectable compositions (FF11) and teaches the use of solubilization aids
such as cyclodextrin, as well as the use of water-soluble polymers. See
Abelson ¶ 46. Based on these teachings in the references, it is not clear why
the use of co-solvents in an injectable formulation would not have the same
expected benefit of improving the solubility of the active agents so that the
formulation can be delivered via injection.
2. Claims 5, 6, and 12
With respect to these rejections, Appellant relies on the same
arguments relied upon with respect to claim 4, discussed above. See Appeal
Br. 28–29. Thus, for the reasons discussed above, we find that Examiner has
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established a prima facie showing of obviousness with respect to claim 4.
Accordingly, we affirm the rejection of claims 5, 6, and 12 as well.
C. Conclusion
We conclude that the preponderance of the evidence of record
supports Examiner’s conclusion that the combination of Cagle, John,
Campos, Peyman, and Scott renders the method of claims 4, 5, 6 and 12 as
obvious. We thus affirm the rejection of claims 4, 5, 6 and 12 under
35 U.S.C. § 103(a) as being obvious.
III. Obviousness over Cagle, John, Scott, Abelson, and Peyman
Appellant does not provide separate arguments from those disclosed
with respect to claim 1 relying on the combination of Cagle, John, Scott,
Abelson, and Peyman as discussed above, see I.B. Appellant contends that
the arguments presented for claim 1 equally apply to claims 2 and 14.
Appeal Br. 29–30; Reply Br. 5.
We conclude, considering the totality of the cited evidence and
arguments, that the preponderance of the evidence supports Examiner’s
conclusion of obviousness with respect to claim 1 (see above I.B.), and
determine that Appellant has not provided sufficient rebuttal evidence or
evidence of secondary considerations that outweighs the evidence
supporting Examiner’s conclusion. As Appellant does not argue the claims
separately, the rejection of claims 2 and 14 is affirmed for the same reasons
discussed above with respect to claim 1 (see above I.B.).
IV. Obviousness over Cagle, John, Scott, and Abelson
Appellant does not provide separate arguments from those disclosed
with respect to claim 1 relying on the combination of Cagle, John, Scott, and
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Abelson as discussed above, see I.B. Appellant contends that the arguments
presented for claim 1 equally apply to claim 16. Appeal Br. 30; Reply Br. 5.
We conclude, considering the totality of the cited evidence and
arguments, that the preponderance of the evidence supports Examiner’s
conclusion of obviousness with respect to claim 1 (see above I.B.), and
determine that Appellant has not provided sufficient rebuttal evidence or
evidence of secondary considerations that outweighs the evidence
supporting Examiner’s conclusion. As Appellant does not argue the claim
separately, the rejection of claim 16 is affirmed for the same reasons
discussed above with respect to claim 1 (see above I.B.).
V. Indefiniteness
Examiner finds that the limitation of the wherein composition “loses
no potency and maintains stability after about 6 months of storage” as
recited in independent claims 1, 4, 13, and 16 is unclear. Final Act. 25; see
Ans. 18.
Appellant contends that the Specification “describes that selecting the
appropriate excipient for use in the pharmaceutical formulations ensures that
the corticosteroid ‘safely forms a stable suspension even when moxifloxacin
is also present in the same formulation.’” Appeal Br. 31 (citing Spec. ¶ 43).
Appellant contends that “the term ‘stable,’ when used in the context of the
claimed suspensions, refers to a suspension that is free from unacceptable
coagulation, clumping and flocculation of solid particles.” Id. at 32 (citing
Spec. ¶¶ 65, 67).
We find that Appellant has the better position. The limitation “loses
no potency and maintains stability after about six months” as recited in the
independent claims is reasonably understood in light of the Specification to
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mean that the composition does not lose potency for a least 6 months, and it
is understood that the composition is free of coagulation, clumping, and
flocculation of solid particles which is known to contribute to loss of
potency. See Spec. ¶¶ 43, 67. There is no requirement that Appellant has to
test the composition beyond 6 months. Therefore, we determine that the
evidence of record does not support Examiner’s conclusion that the claims
are indefinite.

DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 10, 11, 13 103 Cagle, John, Scott,
Abelson, Peyman
1, 10, 11,
13

4–6, 12 103 Cagle, John, Campos,
Peyman, Scott
4–6, 12
2, 14 103 Cagle, John, Scott,
Abelson, Peyman
2, 14
16 103 Cagle, John, Scott,
Abelson
16
1, 4, 13, 16 112 Indefiniteness 1, 4, 13,
16
Outcome 1, 2, 4–6,
10–14,
16

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