Marsh, David A. et al.

Patent Trials and Appeals Board

Oct 23, 2019

13746592 - (D) (P.T.A.B. Oct. 23, 2019)

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.
13/746,592 01/22/2013 David A. Marsh 19017(OCU) 1065
51957 7590 10/23/2019
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
10/23/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
pair_allergan@firsttofile.com
patents_ip@allergan.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DAVID A. MARSH and HONGWEN M. RIVERS
____________

Appeal 2019-003584
Application 13/746,592
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL

Introduction
Appellant1 seeks our review, under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 2–21. (Appeal Brief filed October 2,
2018 (“Br.”) 10.)

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Allergan Inc.
(see Br. 3).
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We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM but
designate our affirmance as a new ground of rejection. See 37 C.F.R.
§ 41.50(b).
Appellant’s Specification provides a composite drug delivery material
including a plurality of drug containing microparticles dispersed in a media
composition which forms a drug depot upon administration. (Specification
dated June 17, 2014 (“Spec.”) ¶ 4.) The Specification discloses that the
media composition may be a low viscosity injectable liquid that forms a
solid or gel after being injected into a body. (Id. at ¶¶ 7, 8.) The
microparticles may include a bioerodible material that erodes in vivo and
releases a drug for a period that is greater than the normal in vivo life of the
drug. (Id. at ¶ 26.)
Appellant’s claim 2 recites:
A method for treating an ocular disease or injury
comprising

injecting into an eye of a mammal in need thereof a
composite drug delivery system

wherein the composite drug delivery system
comprises a plurality of microparticles dispersed in a
media composition,

wherein the media composition is in a low
viscosity, liquid form before injection into the eye and
has a substantially increased viscosity after being injected
into the eye to form a solid or a gel in the eye, and

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wherein the microparticles comprise a drug and a
coating comprising a bioerodible material or a
biodegradable material.

(Br. 24.)
The Examiner rejects the claims as follows (Non-Final Office Action
mailed April 4, 2018 (“Non-Final Act.”)):
Claims 35 U.S.C. § References Non-Final Office
Action Citation
2, 3, 5, 6, 9–11,
and 16–21
102(b) Robinson2 3–5
2–21 103(a) Robinson 5–9

Analysis
1. 35 U.S.C. § 102(b)(pre-AIA) Anticipation
Claims 2, 3, 5, 6, 9–11, and 16
The Examiner finds Robinson discloses a method for treating an
ocular disease by injecting a viscous carrier, e.g., high molecular weight
polymeric hyaluronate, with suspended microspheres containing a
biodegradable material, e.g., poly(lactide-co-glycolide) (“PLGA”), and an
active agent. (Non-Final Act. 3, citing Robinson ¶ 122.) The Examiner
finds Robinson discloses that the viscosity of the carrier is substantially
reduced during injection so that the carrier can be injected into an intraocular
location through a 20 to 30 gauge syringe needle. (Id., citing Robinson
¶¶ 50–53.) Robinson discloses the formulations contain a sufficient
concentration of viscous carrier so as to form a drug depot upon intravitreal

2 Robinson et al., US 2010/0074957 A1, published March 25, 2010.
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injection into a human eye. (Id. at 3–4, citing Robinson ¶ 56.) The
Examiner further finds “Robinson teaches use of microspheres which
contain an active agent coated in PLGA.” (Id. at 9.)
Appellant argues that Robinson does not disclose a media
composition having a low viscosity form before injection into the eye and a
substantially increased viscosity after being injected into the eye to form a
solid or gel. (Br. 13.) Appellant argues that Robinson’s formulation: 1) has
high viscosity pre-injection, 2) is subject to dramatic sheer thinning during
injection, and 3) substantially regains its pre-injection viscosity after
injection. (Id.) Accordingly, Appellant argues Robinson’s formulation has
the same viscosity pre-injection and post-injection. (Id.) In this manner,
Appellant argues further that the drug containing microspheres are trapped
within a viscous plug prior to injection. (Id.)
We are not persuaded by Appellant’s argument. Robinson discloses
that the viscous carrier containing microspheres is injected into the eye
through a narrow space under high shear conditions to substantially reduce
the viscosity. (Robinson ¶ 90.) Robinson discloses that “[a]fter such
passage, the viscous carrier regains substantially its pre-injection viscosity.”
(Id.) Accordingly, before “such passage” or injection into the eye, the
viscous carrier is in a low viscosity liquid form, even if only temporarily.
Moreover, Robinson discloses that the drug containing microspheres are
trapped or held in a “viscous plug” formed “upon intravitreal injection into
the human eye” and not prior to injection as argued by Appellant. (Id. at
¶ 56.) Because Robinson discloses a viscous carrier for microparticles that
is in a low viscosity form at some time before being injected into the eye and
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forms a solid or gel after being injected into the eye, we are not persuaded
that the Examiner erred.
Appellant argues further that Robinson does not disclose
microparticles comprising a drug and a coating of bioerodible material. (Br.
13–14.) Rather, Appellant argues that Robinson discloses that the active
agent can be dispersed within a bioerodible polymer, or associated with a
portion of the bioerodible polymer. (Id. at 14.) Moreover, as to claim 9,
Appellant argues that although Robinson’s microspheres may be made of
PLGA, Robinson does not describe a PLGA coating around the microsphere.
(Id.)
The Examiner responds in the Answer that “Robinson refers to
Hughes (U.S. 2006/0182781) for how to make the microspheres [0011].”
(Examiner’s Answer dated January 31, 2019, (“Ans.”) 8.) The Examiner
finds that Hughes3 teaches a microsphere with a coating covering a core
region comprising a therapeutic component. (Id., citing Hughes ¶ 66.) The
Examiner is asserting that Robinson incorporates Hughes and that a skilled
artisan reading Robinson would immediately envisage coating the active
agent with PLGA. (Id.)
We are persuaded by Appellant’s argument. Hughes, which is
referenced by Robinson for making microspheres for intraocular use,
discloses at least two different types of sustained release microsphere, e.g., a
biodegradable polymer matrix and a coated therapeutic core. (See Hughes
¶ 66.) To anticipate, a reference must clearly and unequivocally direct those
skilled in the art to the claimed invention “without any need for picking,

3 Hughes et al., US 2006/0182781 A1, published August 17, 2006.
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choosing, and combining various disclosures not directly related to each
other. . . . Such picking and choosing may be entirely proper in the making
of a 103, obviousness rejection . . . but it has no place in the making of a
102, anticipation rejection.” In re Arkley, 455 F.2d 586, 587 (CCPA 1972).
Because identifying the element of coated microspheres requires picking and
choosing from different types of microspheres, we do not sustain the
Examiner’s rejection of claim 2 as anticipated. The rejection of claims 3, 5,
6, 9–11, and 16, which depend from claim 2, is likewise reversed .
Claims 17–21
Independent claim 17 differs from claim 2 in that: 1) claim 17 recites
“wherein the drug is present in the plurality of microparticles and the drug is
dispersed in the depot forming materials,” and 2) claim 17 does not recite “a
coating comprising a bioerodible material or a biodegradable material.” (Br.
26.)
As discussed above, the Examiner finds Robinson teaches a method
for treating an ocular disease by injecting a composite drug delivery system
including drug containing microparticles which are dispersed in a viscous
carrier. (Ans. 3.) The viscous carrier is in a low viscosity form as it is
injected into the eye and forms a high viscosity drug depot after being
injected into the eye. (Id.) The Examiner determines that the claims “do not
specify that the drug dispersed in the depot forming material must be
separate from the drug contained in the microparticles.” (Id. at 8–9.)
Accordingly, the Examiner finds that the drug in the dispersed
microparticles is also dispersed in the depot forming material. (Id. at 8.)
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Appellant argues “Claim 17 requires drug in two separate places: 1) in
the microparticles; and 2) in the depot forming material (‘media drug’).” (Br.
16.) Appellant argues that the Specification describes drug not located in the
microparticles that is encapsulated in the drug depot and permeates prior to
the drug within the microparticles. (Id., citing Spec. ¶ 18.) Appellant argues
that Robinson only teaches drugs in microspheres, and not drug in the depot
forming material. (Id.)
We are not persuaded by Appellant’s argument. As explained by the
Examiner, the plain meaning of the claims does not require that the drug
present in the microparticles is distinct from the drug dispersed in the depot
forming material. The broadest reasonable interpretation of the claims
allows for microparticles containing a drug to be dispersed in the depot,
thereby dispersing the drug throughout the depot as well. Appellant’s
proposed interpretation imports limitations from the specification into the
claims. “[W]hile it is true that claims are to be interpreted in light of the
specification and with a view to ascertaining the invention, it does not follow
that limitations from the specification may be read into the claims.” Sjolund
v. Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988). Therefore, we are not
persuaded that the Examiner erred and we sustain the rejection of claim 17
as anticipated by Robinson.
Claim 18 recites “wherein the plurality of microspheres comprises a
coating.” (Br. 26.) Appellant cites to the previous argument that Robinson
does not disclose a coating on the microspheres. As discussed above,
Robinson does not disclose microspheres with a coating without picking and
choosing by reference to Hughes. Accordingly, for the reasons set forth
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above, we do not sustain the rejection of claim 18. The rejection of claims
19–21, which depend from claim 18, falls for the same reason.

2. 35 U.S.C. § 103(a)(pre-AIA) Obviousness
Claims 2–21
The Examiner rejects claims 2–21 as obvious over Robinson. As
discussed above, the Examiner finds Robinson’s reference to Hughes
teaches drug containing microparticles coated with a bioerodible material.
(Ans. 4.) Particularly, Hughes teaches that “[a] drug release sustaining
component may be a biodegradable polymer matrix, or it may be a coating
covering a core region of the microsphere that comprises a therapeutic
component.” (Hughes ¶ 66.) In the Answer, the Examiner determines that
Robinson incorporates Hughes by reference, and therefore, rejects the claims
as obvious over Robinson alone. (See Ans. 4–5.)
Unlike the anticipation rejection, picking and choosing from different
options of microspheres is entirely proper in the making of a 103,
obviousness rejection. Arkley, 455 F.2d at 587. Therefore, we agree with
the Examiner that it would have been prima facie obvious to a person of
ordinary skill in the art to prepare drug containing microspheres with a
bioerodible coating or a bioerodible polymer matrix as taught by Robinson.
Nevertheless, had the Examiner presented this argument in the Non-
Final Rejection, not only in the response to Appellant’s arguments on
appeal, we would have little difficulty in affirming the rejection. Appellant
did not file a Reply Brief and thus chose not to address the incorporation by
reference. However, “[w]here a reference is relied on to support a rejection,
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whether or not in a ‘minor capacity,’ there would appear to be no excuse for
not positively including the reference in the statement of the rejection.” In
re Hoch, 428 F.2d 1341, 1342 n. 3 (CCPA 1970). The Examiner did not
explain the incorporation by reference in the Non-Final Action. For this
reason, we designate the affirmance as a new ground of rejection to allow
Appellant a fair opportunity to address this teaching.
Appellant submits the Declaration of Dr. Hongwen Rivers, Ph.D.
dated May 18, 2016 (“Rivers Decl.”) to demonstrate superior and
unexpected results over Robinson. Dr. Rivers states that the carrier of
Robinson is highly viscous before administration and thus would be more
difficult to prepare. (Rivers Decl. ¶ 3.) Dr. Rivers also states that the gels
taught in Robinson are expected to have shorter residence times and be
cleared away within 1 week in contrast with the claimed gels, which are
expected to last weeks, months, or years. (Id. ¶¶ 5, 7.) Dr. Rivers states
further that the claimed media composition is a liquid solution before dosing
and is an improvement over Robinson’s viscous carrier. (Id. ¶ 6.) Finally,
the Dr. Rivers states that a mixture of sustained release microspheres allows
for a variation of release durations, unlike Robison’s microspheres. (Id. ¶ 8).
We are not persuaded by the evidence presented in the Declaration.
“To be particularly probative, evidence of unexpected results must establish
that there is a difference between the results obtained and those of the closest
prior art, and that the difference would not have been expected by one of
ordinary skill in the art at the time of the invention.” Bristol-Myers Squibb
Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). Dr.
Rivers does not present evidence of unexpected results, but instead refers to
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differences between the teachings of Robinson and the claimed methods.
Moreover, none of these difference would be appear to be unexpected
improvements over the modifications taught in Robinson. For example,
Robinson teaches adjusting the viscosity of the viscous carrier as needed.
(See Robinson ¶¶ 88, 91, 94.) Moreover, Robinson teaches using a drug
depot containing a variety of microspheres to obtain drug release for a time
period between about 50 days to about 1 year. (See Robinson ¶¶ 41, 86.)
Accordingly we are not persuaded that the Examiner erred in rejecting
claims 2–21 as obvious over Robinson.
Appellant separately lists dependent claims 3, 5, 6, 9, 10, 11, 16, and
18–21. (Br. 14–15.) As discussed above, Robinson teaches coated
microspheres, including a PLGA coating, by incorporating Hughes.
Therefore, we affirm the Examiner’s rejection of claims 9 and 18 as obvious
over Robinson. Appellant does not present separate arguments for
patentability of claims 3–8, 10–11, 16, and 19–21 other than merely pointing
out what the claims recite. Because a statement that merely points out what
a claim recites will not be considered an argument for separate patentability
of the claim, we affirm the Examiner’s rejection of these claims. See 37
C.F.R. § 41.37(c)(1)(iv). Accordingly, we affirm the Examiner’s rejection
of claims 2–21.

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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § References/
Basis
Affirmed Reversed New
Grounds
2, 3, 5, 6,
9–11, 16–
21
102(b) Robinson 17 2, 3, 5, 6, 9–
11, 16, 18–
21

2–21 103(a) Robinson 2–21 2–21
Overall
Outcome
2–21 2–21

We designate our affirmance as a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides that “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
examiner, in which event the proceeding will be remanded to
the examiner . . . .

(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same record.

AFFIRMED
37 C.F.R. § 41.50(b)