Heron Therapeutics, Inc.

Patent Trials and Appeals Board

Sep 2, 2020

2020001510 (P.T.A.B. Sep. 2, 2020)

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.
15/621,782 06/13/2017 Thomas B. Ottoboni 092459-0213/8026.US06 9963
108547 7590 09/02/2020
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001
EXAMINER
LIU, TRACY
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
09/02/2020 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):
mweipdocket@mwe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte THOMAS B. OTTOBONI and
LEE ANN LYNN GIROTTI1
________________

Appeal 2020-001510
Application 15/621,782
Technology Center 1600
________________

Before ERIC B. GRIMES, JOHN G. NEW, and MICHAEL A. VALEK,
Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the term “Appellant” to refer to the “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Heron Therapeutics, Inc. as the real
party-in-interest. App. Br. 1.
Appeal 2020-001510
Application 15/621,782

2
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1–8, 15–19, 25–35, 40–45, 47, and
53–59. Specifically, claims 1–8, 15–19, and 25–33 stand rejected as
unpatentable under 35 U.S.C. § 103 as being obvious over the combination
of Ng et al. (US 2012/0283253 A1, November 8, 2012) (“Ng”) and
Wohabrebbi (US 2010/0015049 A1, January 21, 2010) (“Wohabrebbi”).
Claims 34, 35, 40–45, 47, and 53–59 stand rejected as unpatentable
under 35 U.S.C. § 103 as being obvious over the combination of Ng,
Wohabrebbi, and Dadey et al. (US 2008/0299168 A1, December 4, 2008)
(“Dadey”).
Claims 1–8, 15–19, 25–35, 40–45, 47, and 53–592 also stand rejected
as unpatentable under the nonstatutory doctrine of obviousness-type double
patenting as being obvious over claims 1, 6, and 7 of US 9,744,163 B2;
August 29, 2017 (the “’163 patent”), claim 1 of US 9,592,227 B2; March 14,
2017 (the “’227 patent”), and claims 1 and 8 of US 9,913,909 B2; March 13,
2018 (the “’909 patent”), Ng, and Wohabrebbi.
Claims 1–8, 15–19, 25–35, 40–45, 47, and 53–59 stand further
provisionally rejected as unpatentable under the nonstatutory doctrine of
obviousness-type double patenting as being obvious over claim 1 of
copending US Ser. No. 14/691,491 (the “’491 application”) and claims 1 and

2 Appellant states that claims 1–8, 15–19, 25–35, and 40–59 are rejected as
unpatentable in both obviousness-type double patenting rejections. App.
Br. 3. However, claims 46 and 48–52 have been canceled. See App. Br.
18–19 (Claims Appendix).
Appeal 2020-001510
Application 15/621,782

3
9 of copending US Ser. No. 15/457,545 (the “’545 application”), Ng, and
Wohabrebbi.3
Claims 1–8, 15–19, 25–35, 40–45, 47 and 53–59 are provisionally
rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1–40 of copending US Ser. No. 15/331,759 (the
“’759 application”).
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

NATURE OF THE CLAIMED INVENTION
Appellant’s claimed invention is directed to compositions comprising
a delivery vehicle or delivery system and an active agent dispersed within
the delivery vehicle or system, wherein the delivery vehicle or system
contains a polyorthoester polymer and a polar aprotic solvent. The
compositions include an amide- or anilide-type local anesthetic of the
“caine” classification, and a non-steroidal anti-inflammatory drug
(“NSAID”). Abstr.

REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A composition, comprising: an amide local anesthetic, an
enolic-acid non-steroidal anti-inflammatory drug (NSAID) and a
delivery vehicle, wherein the enolic-acid non-steroidal NSAID is
the sole NSAID comprised in the composition.

3 The Examiner also rejected claims 33 and 58 as unpatentable under 35
U.S.C. § 112(b) as being indefinite. Final Act. 2. The Examiner has
withdrawn this rejection. Ans. 5.
Appeal 2020-001510
Application 15/621,782

4

App. Br. 13.

ISSUES AND ANALYSES
We decline to adopt the Examiner’s findings, reasoning, and
conclusion that the claims on appeal are prima facie obvious over the cited
prior art. However, we do not reach the rejection of claims 1–8, 15–19, 25–
35, 40–45, 47 and 53–59 over the ’759 application. We address the
arguments raised by Appellant below.

A. Rejection of claims 1–8, 15–19, 25–35, 40–45, 47, and 53–59 under
35 U.S.C. § 103

Issue 1

Appellant argues that the Examiner erred in finding that a person of
ordinary skill in the art would have been motivated to combine the teachings
of the cited prior art references to arrive at Appellant’s claimed
compositions. App. Br. 4.

Analysis
The Examiner finds that Ng teaches, inter alia, compositions
comprising active agents including any compound or mixture of compounds
which produces a beneficial or useful result. Final Act. 4. The Examiner
finds that Ng teaches examples of these active agents, including anti-
inflammatory agents and amide-type local anesthetics such as bupivacaine.
Id. (citing Ng ¶ 23). The Examiner finds that Ng also teaches that the
concentration of the active agent in the semi-solid polyorthoester
composition can vary over a wide range (e.g., 0.1–80 wt%), depending on a
Appeal 2020-001510
Application 15/621,782

5
variety of factors, such as the release profile of the composition, the
therapeutically effective dose of the active agent, and the desired length of
the interval during which the active agent is released. Id. (citing Ng ¶ 75).
The Examiner acknowledges that Ng neither teaches nor suggests that
its compositions comprise an enolic-acid non-steroidal anti-inflammatory
drug (“NSAID”). Final Act. 5. However, the Examiner finds, Wohabrebbi
teaches methods and compositions for reducing, treating or preventing post-
operative pain and/or inflammation comprising administration of one or
more biodegradable drug depots comprising a therapeutically effective
amount of diclofenac and/or ketoprofen to a target tissue site. Final Act. 5
(citing Wohabrebbi Abstr.). The Examiner finds that Wohabrebbi also
teaches the inclusion in its compositions of other therapeutic agents
including meloxicam, as an NSAID, and bupivacaine as an analgesic agent.
Id. at 6 (citing Wohabrebbi ¶¶ 45, 47).
The Examiner concludes that it would have been obvious for a person
of ordinary skill in the art to incorporate meloxicam into the compositions
taught by Ng, because it was a known anti-inflammatory agent, as taught by
Wohabrebbi. Final Act. 6.
Appellant argues that Ng neither teaches nor suggests an enolic-acid
non-steroidal anti-inflammatory drug as the active agent, much less a
combination of an amide local anesthetic and an enolic-acid non-steroidal
anti-inflammatory drug as recited in the claims. App. Br. 5. Appellant
acknowledges that Ng teaches a composition comprising an active agent and
a semi-solid delivery vehicle. Id. (citing Ng ¶ 9). Appellant also notes that
Ng teaches that the active agent includes any compound or mixture of
compounds, which produces a beneficial or useful result, and teaches a
Appeal 2020-001510
Application 15/621,782

6
“laundry list” of active agents. Id. (citing Ng ¶ 23). Appellant argues that
Ng teaches anti-inflammatory agents only as an example of an active agent,
and does not distinguish enolic-acid non-steroidal anti-inflammatory drugs
from other anti-inflammatory agents, nor does it list any enolic-acid non-
steroidal anti-inflammatory drugs among the exemplified anti-inflammatory
agent (e.g., aspirin, ibuprofen, naproxen, ketorolac, COX-1 inhibitors, COX-
2 inhibitors, etc.). Id.
Appellant contends that, other than Ng’s broad teaching that the active
agent can include any compound or a mixture of compounds which produces
a beneficial or useful result, Ng neither teaches nor exemplifies a
composition comprising a mixture of any particular compounds. App. Br. 6.
Therefore, argues Appellant, Ng does not teach or suggest a composition
comprising an amide local anesthetic and an enolic-acid non-steroidal anti-
inflammatory drug, as recited in the claims. Id. Appellant asserts that “[t]he
fact that a claimed species or subgenus is encompassed by a prior art genus
is not sufficient by itself to establish a prima facie case of obviousness.” Id.
at 7 (citing In re Jones, 958 F.2d 347, 350 (Fed. Cir. 1992) (holding that
“We decline to extract from Merck the rule … that regardless of how broad,
a disclosure of a chemical genus renders obvious any species that happens to
fall within it”); see also MPEP§ 2144.08)). Appellant also points to our
reviewing court’s holding that the disclosure of an active ingredient that can
be contained in a formulation is insufficient by itself to invalidate a claim
directed to a formulation comprising the active ingredient. Id. at 8 (citing
Impax Labs., Inc. v. Lannett Holdings Inc., 893 F.3d 1372, 1379 (Fed. Cir.
2018)).
Appeal 2020-001510
Application 15/621,782

7
Turning to Wohabrebbi, Appellant argues that the reference teaches
compositions comprising diclofenac and/or ketoprofen that have analgesic
and anti-inflammatory effect, used in single or multiple drug depots. App.
Br. 9 (citing Wohabrebbi ¶ 10). Appellant notes, and it is not disputed by
the Examiner, that diclofenac and ketoprofen are both NSAIDs and,
furthermore, are both carboxylate, and not enolate, NSAIDs. Id. (citing
Wohabrebbi ¶¶ 4, 5).
Appellant acknowledges that Wohabrebbi further teaches that, in
addition to diclofenac and/or ketoprofen, the compositions may comprise
one or more additional therapeutic agents, including anti-inflammatory agent
and analgesic agents. App. Br. 9 (citing Wohabrebbi ¶¶ 42, 49). Among
these, Appellant notes, are meloxicam (an enolic acid-based NSAID) as an
anti-inflammatory agents and bupivacaine as an amide analgesic agent. Id.
at 9–10 (citing Wohabrebbi ¶¶ 45, 47).
Appellant contends that the Examiner has provided no rationale with
respect to why a person of ordinary skill in the art would have chosen
meloxicam, an optional NSAID, over diclofenac and/or ketoprofen, both
required by Wohabrebbi for analgesic and anti-inflammatory effect, or over
any of the other optional NSAIDs taught in paragraph [0045], and then to
have incorporated it into the compositions taught by Ng. App. Br. 10.
Appellant contends that Wohabrebbi teaches, at most, combining meloxicam
as an optional agent with diclofenac, and provides no suggestion to combine
meloxicam with a local amide anesthetic. Id. at 11.
The Examiner responds that it is, generally, prima facie obvious to
select a known material for incorporation into a composition, based on its
recognized suitability for its intended use. Ans. 6 (citing MPEP § 2144.07).
Appeal 2020-001510
Application 15/621,782

8
The Examiner therefore concludes that it would have been obvious to a
person of ordinary skill in the art to have incorporated meloxicam (i.e., an
enolic-acid non-steroidal anti-inflammatory drug) into the composition of
Ng, because Wohabrebbi teaches that meloxicam is well known in the art as
an anti-inflammatory agent. Id.
We are not persuaded by the Examiner’s reasoning. As an initial
matter, we agree with Appellant that the teachings of Ng are too broad to
adequately describe a genus of which a person of ordinary skill in the art
would recognize the claimed compositions to be a member. See Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010):
[A] sufficient description of a genus instead requires the
disclosure of either a representative number of species falling
within the scope of the genus or structural features common to
the members of the genus so that one of skill in the art can
“visualize or recognize” the members of the genus.

Ng teaches that an “active agent”:
[I]ncludes any compound or mixture of compounds which
produces a beneficial or useful result. Active agents are
distinguishable from such components as vehicles, carriers,
diluents, lubricants, binders and other formulating aids, and
encapsulating or otherwise protective components. Examples of
active agents and their pharmaceutically acceptable salts, are
pharmaceutical, agricultural or cosmetic agents.

Ng ¶ 23. Ng elaborates that:
Suitable pharmaceutical agents include locally or systemically
acting pharmaceutically active agents which may be
administered to a subject by topical or intralesional application
(including, for example, applying to abraded skin, lacerations,
puncture wounds, etc., as well as into surgical incisions) or by
injection, such as subcutaneous, intradermal, intramuscular,
intraocular, or intra-articular injection. Examples of these agents
Appeal 2020-001510
Application 15/621,782

9
include, but not limited to, anti-infectives (including antibiotics,
antivirals, fungicides, scabicides or pediculicides), antiseptics
(e.g., benzalkonium chloride, benzethonium chloride,
chlorhexidine gluconate, mafenide acetate, methylbenzethonium
chloride, nitrofurazone, nitromersol and the like), steroids (e.g.,
estrogens, progestins, androgens, adrenocorticoids, and the like),
therapeutic polypeptides (e.g.[,] insulin, erythropoietin,
morphogenic proteins such as bone morphogenic protein, and the
like), analgesics and anti-inflammatory agents (e.g., aspirin,
ibuprofen, naproxen, ketorolac, COX-1 inhibitors, COX-2
inhibitors, and the like), cancer chemotherapeutic agents (e.g.,
mechlorethamine, cyclophosphamide, fluorouracil, thioguanine,
carmustine, lomustine, melphalan, chlorambucil, streptozocin,
methotrexate, vincristine, bleomycin, vinblastine, vindesine,
dactinomycin, daunorubicin, doxorubicin, tamoxifen, and the
like), narcotics (e.g., morphine, meperidine, codeine, and the
like), local anesthetics (e.g., the amide- or anilide-type local
anesthetics such as bupivacaine, dibucaine, mepivacaine,
procaine, lidocaine, tetracaine, and the like), antiemetic agents
such as ondansetron, granisetron, tropisetron, metoclopramide,
domperidone, scopolamine, and the like, antiangiogenic agents
(e.g., combrestatin, contortrostatin, anti-VEGF, and the like),
polysaccharides, vaccines, antigens, DNA and other
polynucleotides, antisense oligonucleotides, and the like. The
present invention may also be applied to other locally acting
active agents, such as astringents, antiperspirants, irritants,
rubefacients, vesicants, sclerosing agents, caustics, escharotics,
keratolytic agents, sunscreens and a variety of dermatologics
including hypopigmenting and antipruritic agents. The term
“active agents” further includes biocides such as fungicides,
pesticides, and herbicides, plant growth promoters or inhibitors,
preservatives, disinfectants, air purifiers and nutrients. Prodrugs
of the active agents are included within the scope of the present
invention.

Id. (emphasis added). We quote this lengthy passage in full to illustrate the
very considerable breadth of the genus of “active agents” taught by Ng. We
agree with Appellant that it would not have been obvious from this teaching
Appeal 2020-001510
Application 15/621,782

10
of Ng to select a composition “comprising[ ] an amide local anesthetic, an
enolic-acid non-steroidal anti-inflammatory drug (NSAID),” as recited in the
claims.
However, we also note that Ng is primarily directed to a “semi-solid
delivery vehicle which comprises a polyorthoester and an excipient. The
excipient is readily miscible with the polyorthoester and the resulting semi-
solid delivery vehicle has a smooth and flowable texture” (see Ng ¶ 8). We
surmise, the Examiner’s stated findings and Appellant’s arguments in this
appeal notwithstanding, that it is upon this teaching of a polymeric and,
specifically, a polyorthoester, delivery vehicle that the Examiner relies upon
Ng as teaching. See, e.g., dependent claim 15, which recites, “wherein the
sustained-release delivery vehicle is a polymeric formulation in the form of a
semi-solid polymer formulation comprising a polymer, the amide local
anesthetic and the enolic-acid NSAID”; see also claim 18, which recites,
“wherein the polymer is selected from the group consisting of polylactides,
polyglycolides, poly(lactic-co-glycolic acid) copolymers, polycaprolactones,
poly-3-hydroxybutyrates, and polyorthoesters” (emphasis added).
With respect to Wohabrebbi, the reference is directed to “methods and
compositions comprising administering one or more biodegradable drug
depots comprising a therapeutically effective amount of diclofenac and/or
ketoprofen or pharmaceutically acceptable salt thereof to a target tissue site.”
Wohabrebbi Abstr. Specifically, Wohabrebbi teaches “diclofenac and/or
ketoprofen compositions and methods are provided that have long acting
analgesic and anti-inflammatory effects over periods of 3 to 15 days in a
single drug depot or multiple drug depots.” Id. at ¶ 10.
Wohabrebbi further teaches that:
Appeal 2020-001510
Application 15/621,782

11
In addition to diclofenac and/or ketoprofen, the drug depot may
comprise one or more additional therapeutic agents.
….
Specific examples of therapeutic agents suitable for use include,
but are not limited to an anti-inflammatory agent, analgesic
agent, or osteoinductive growth factor or a combination thereof.
Anti-inflammatory agents include, but are not limited to,
salicylates, diflunisal, sulfasalazine, indomethacin, ibuprofen,
naproxen, tolmetin, ketorolac, fenamates (mefenamic acid,
meclofenamic acid), enolic acids (piroxicam, meloxicam)
….
Suitable analgesic agents include, but are not limited to,
acetaminophen, lidocaine, bupivicaine….

Id. at ¶¶ 42, 45, 47 (emphases added). Wohabrebbi thus teaches that, inter
alia, an amide local anesthetic (e.g., bupivacaine) and an enolic-acid non-
steroidal anti-inflammatory drug, as recited in claim 1 may be optional
constituents of its disclosed compositions in addition to diclofenac and/or
ketoprofen, which are carboxylate-based NSAIDs (see App. Br. 9, this is not
disputed by the Examiner).
Independent claim 1 recites: “A composition, comprising: an amide
local anesthetic, an enolic-acid non-steroidal anti-inflammatory drug
(NSAID) and a delivery vehicle, wherein the enolic-acid non-steroidal
NSAID is the sole NSAID comprised in the composition” (emphasis added).
Claim 40, the only other independent claim on appeal, also recites the
limitation in italics quoted above. We construe that limitation as a negative
limitation, because it serves to exclude any additional NSAIDs (enolate- and
carboxylate-based alike) from Appellant’s claimed composition.
Appellant’s Specification supports this negative limitation, disclosing
that:
Appeal 2020-001510
Application 15/621,782

12
Interestingly, it appears that not all NSAIDs are effective in
enhancing the effect of a locally administered amide-type
anesthetic. As described in Example 7, an illustrative
composition comprising a polyorthoester as a delivery vehicle
and bupivacaine and 7.5 wt% diclofenac (having a proton-
donating carboxylic acid group) failed to regain its short-term
efficacy after about 1 day following application or more, and
provided significantly less pain relief over the time frame of 1 to
5 days following application when compared to its early, short-
term efficacy up to about 5 hours post-application. This is in
distinct contrast to the bupivacaine-meloxicam [an enolate-based
NSAID] composition.

Spec. ¶ 177; See Santarus, Inc. v. Par Pharm. Inc., 694 F.3d 1344 (Fed Cir.
2012) (holding that: “Negative claim limitations are adequately supported
when the specification describes a reason to exclude the relevant
limitation”).
Appellant’s claims thus expressly exclude the carboxylate-based
NSAIDs diclofenac and/or ketoprofen from its compositions. The Examiner
has articulated no reason or motivation with respect to why a person of
ordinary skill in the art would have been motivated to select the amide local
anesthetic and enolic-acid NSAID constituents from the lists of additional,
and optional, elements of the compositions taught by Wohabrebbi, and
simultaneously exclude the required carboxylate NSAIDs diclofenac and/or
ketoprofen from the composition. Absent any such reasoning articulated by
the Examiner, we are not persuaded that the Examiner has established a
prima facie case of obviousness, and we reverse the Examiner’s rejection.
Furthermore, because we reverse the Examiner’s rejection in this respect, we
do not reach Appellant’s additional arguments with respect to this rejection.

Appeal 2020-001510
Application 15/621,782

13
B. Rejection of claims 1–8, 15–19, 25–35, 40–45, 47, and 53–59 under
the nonstatutory doctrine of obviousness-type double patenting

Appellant relies upon essentially the argument presented supra,
arguing that both the obviousness-type double patenting and the provisional
obviousness-type double patenting rejection are based on the Examiner’s
allegedly improper conclusion that Ng and Wohabrebbi render obvious the
claimed composition. App. Br. 11; see also Final Act. 13–14. Because we
reverse the Examiner’s conclusion that the claims on appeal are obvious
under 35 U.S.C. § 103 over Ng and Wohabebbi, we conclude that the
provisional and non-provisional obviousness-type double patenting
rejections that also cite Ng and Wohabrebbi4 must similarly be reversed.
We do not reach the provisional rejection of claims 1–8, 15–19, 25–
35, 40–45, 47 and 53–59 over the ’759 application. Neither Appellant’s
Brief, nor the Examiner’s Answer, have provided arguments on the merits
directed to the claims of the ’759 application. However, because we have
reversed Examiner’s other rejections and “[t]he only remaining rejection is a
provisional non-statutory double patenting rejection,” we determine it is
“premature” to address this rejection and consequently do not reach it. In re
Moncla, 95 USPQ2d 1884 (BPAI 2010) (precedential).

4 That is, the rejection of claims 1–8, 15–19, 25–35, 40–45, 47, and 53–59
as unpatentable over claims 1, 6, and 7 of the ’163 patent, claim 1 of the
’227 patent, and claims 1 and 8 of the ’909 patent, Ng, and Wohabrebbi,
and the provisional rejection of claims 1–8, 15–19, 25–35, 40–45, 47, and
53–59 over claim 1 of the copending ’491 application and claims 1 and 9
of the ’545 application, Ng, and Wohabrebbi.
Appeal 2020-001510
Application 15/621,782

14
CONCLUSION
The Examiner’s rejection of claims 1–8, 15–19, 25–35, 40–45, 47,
and 53–59 under 35 U.S.C. § 103 is reversed.
The Examiner’s rejection of claims 1–8, 15–19, 25–35, and 40–59
under the nonstatutory doctrine of obviousness-type double patenting is
reversed.

REVERSED
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–8, 15–
19, 25–33
103 Ng,
Wohabrebbi

1–8, 15–
19, 25–33
34, 35,
40–45, 47,
53–59
103 Ng, Wohabrebbi,
Dadey
34, 35, 40–
45, 47, 53–
59
1–8, 15–
19, 25–35,
40–45, 47,
53–59
Non-statutory
Double Patenting:
’163 patent, ’227,
patent, ’909
patent,
Ng, Wohabrebbi
1–8, 15–
19, 25–35,
40–45, 47,
53–59
1–8, 15–
19, 25–35,
40–45, 47,
53–59
Provisional Non-
statutory Double
Patenting: ’491
application, ’545
application, Ng,
Wohabrebbi
1–8, 15–
19, 25–35,
40–45, 47,
53–59
1–8, 15–
19, 25–35,
40–45, 47,
53–59
Provisional Non-
statutory Double
Patenting: ’759
application5

5 As explained above, we do not reach this rejection per Ex parte Moncla, 95
USPQ2d 1884 (BPAI 2010) (designated precedential).
Appeal 2020-001510
Application 15/621,782

15
Overall
Outcome
1–8, 15–
19, 25–35,
40–45, 47,
53–59