Patricia Salvati et al.

Patent Trials and Appeals Board

Dec 12, 2019

12544456 - (D) (P.T.A.B. Dec. 12, 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.
12/544,456 08/20/2009 Patricia Salvati SS122-1082 9382
122515 7590 12/12/2019
Silvia Salvadori, P.C.
Silvia Salvadori
270 Madison Avenue, 8th Floor
New York, NY 10016
EXAMINER
BAEK, BONG-SOOK
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
12/12/2019 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):
eofficeaction@appcoll.com
silvia30121@me.com
silvia@salvadorilaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PATRICIA SALVATI, ORIETTA VENERONI,
ELENA BARBANTI, FARIELLO RUGGERO, and
LUCA BENATTI
__________

Appeal 2018-009049
Application 12/544,456
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, ROBERT A. POLLOCK, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a
method of treating inflammation. The Examiner rejected the claims as
obvious and for obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse the obviousness rejection but affirm the
double patenting rejection.

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 NEWRON
PHARMACEUTICALS S.P.A. (See Appeal Br. 3).
2 We have considered and refer to the Specification of Aug. 20, 2009
(“Spec.”); Final Action of Jan. 11, 2018 (“Final Act.”); Appeal Brief of May
8, 2018 (“Appeal Br.”); Examiner’s Answer of Aug. 3, 2018 (“Ans.”); and
Reply Brief of Sept. 21, 2018 (“Reply Br.”). We also note our previous
Decision on June 21, 2017 (“Dec.”).
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Statement of the Case
Background
“Inflammation produces profound changes in the excitability of
primary afferent neurons innervating the inflamed tissue. . . . Studies have
shown that post-translational modification or abnormal expression of sodium
channels in dorsal root ganglion (DRG) neurons occurs after tissue
inflammation” (Spec. 1:8–12). “The invention relates to α-aminoamide
derivatives, a chemical class of sodium channel blockers, which are useful as
anti-inflammatory agents” (Spec. 1:3–4).
The Claims
Claims 10, 11, 14, and 15 are on appeal. Claim 10 is representative
and reads as follows:
10. A method of treating inflammation from one or more
inflammatory disorders in a human patient in need thereof, the
method consisting of administering to said patient an amount
ranging from about 0.3 to about 100 mg/kg body weight per
day of at least one anti-inflammatory agent consisting of an α-
aminoamide compound of formula (I),
.

wherein:
A is a -(CH2)n-X-group, wherein n is an integer of 0 to 5,
and X is CH2, -O-, -S-or -NH-;
s is 1 or 2;
R is a furyl, thienyl, or pyridyl ring or a phenyl
ring, optionally substituted by one or two substituents
independently selected from halogen, hydroxy, cyano, C1-C6
alkyl, C1-C6 alkoxy or trifluoromethyl;
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R1 is hydrogen or C1-C6 alkyl or C3-C7 cycloalkyl;
R2 and R3 are independently selected from
hydrogen, C1-C4 alkyl, optionally substituted by hydroxy or
phenyl; phenyl, optionally substituted by one or two
substituents independently selected from C1-C6 alkyl, halogen,
hydroxy, C1-C6 alkoxy or trifluoromethyl; or R2 and R3, taken
with the carbon atom which they are linked to, form a C3-C6
cycloalkyl ring; and
R4 and R5 are independently hydrogen, C1-C6 alkyl
or C3-C7 cycloalkyl; or R4 and R5, taken together with the
nitrogen atom they are linked to, form a 5 to 7 atom saturated
heterocyclic ring; and/or
isomers, mixtures, and/or pharmaceutically acceptable
salts or esters thereof, such that inflammation is reduced or
prevented,
wherein said one or more inflammatory disorders are
selected from the group consisting of alkylosing spondylitis,
cervical arthritis, fibromyalgia, gout, juvenile rheumatoid
arthritis, lumbosacral arthritis, osteoarthritis, osteoporosis,
psoriatic arthritis, rheumatic disease, rheumatoid arthritis,
eczema, psoriasis, dermatitis, sunburn, inflammatory eye
conditions, uveitis, conjunctivitis, inflammatory lung disorders,
asthma and bronchitis.

The issues3
A. The Examiner rejected claims 10, 11, 14, and 15 under 35 U.S.C.
§ 103(a) as obvious over Pevarello4 and Selve5 (Ans. 4–7).

3 We note that in response to a requirement for a species election, Appellant
elected the species of (S)-(+)-2-[4-(2-fluorobenzyloxy) benzylamino]-
propanamide (see Resp. Restriction Req. Nov. 17, 2011). We therefore limit
our consideration of the merits of the appealed rejection to the elected
species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987).
4 Pevarello et al., US 6,306,903 B1, issued Oct. 23, 2001.
5 Selve, US 2003/0171300 A1, published Sept. 11, 2003.
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B. The Examiner rejected claims 10, 11, 14, and 15 on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 41 and 45 of US RE40,2596 (Ans. 7–8).

A. 35 U.S.C. § 103(a) over Pevarello and Selve
The Examiner finds Pevarello teaches “administering a therapeutically
effective amount of an alpha aminoamide compound of formula (I)
including 2-[4-(2-fluorobenzyloxy)-benzylamino]-propanamide, which is
useful in humans as analgesic agents, for treating chronic pain or
neuropathic pain” (Final Act. 3). The Examiner finds Pevarello teaches
“doses of 7.5, 15, 30, and 60 mg/kg” (id.). The Examiner acknowledges that
Pevarello “does not specifically disclose rheumatoid arthritis or
osteoarthritis as a pain condition” (id. at 4).
The Examiner finds that Selve teaches “analgesic agents which are
useful for treating acute or chronic pain are also useful for treating other pain
conditions including rheumatoid arthritis pain and osteoarthritis pain” (Final
Act. 5). The Examiner finds it obvious to use the alpha aminoamide
compound “for treating a patent [sic] with pain conditions such as
rheumatoid arthritis and osteoarthritis since [Selve] clearly teaches that the
alpha aminoamide compound is as an analgesic agent demonstrated by
formalin test and thus useful for treating pain conditions” (id.).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Pevarello and Selve render the
claims obvious?

6 Pevarello et al., US RE40,259 E, reissued on Apr. 22, 2008 (“US
RE40,259”).
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Findings of Fact
1. Pevarello teaches “a method of treating a mammal, including
humans, in need of an analgesic agent, said method comprising
administering thereto an effective amount of” α-aminoamide compounds
including “2-[4-(2-fluorobenzyloxy)benzylamino]propanamide” (Pevarello
2:56 and 3:29–32).
2. Pevarello teaches: “Examples of pain conditions that can be
treated by a compound of formula (I) include . . . multiple sclerosis”
(Pevarello 3:34–42).
3. Pevarello teaches:
“Treatment” as used herein covers any treatment of a condition
in a mammal, particularly a human, and includes: (i) preventing
the disease from occurring in a subject which may be
predisposed to the disease, but has not yet been diagnosed as
having it; (ii) inhibiting the condition, i.e., arresting its
development; or (iii) relieving the condition, i.e., causing
regression of the disease.

(Pevarello 3:42–51).
4. Pevarello teaches “doses of 7.5, 15.0, 30.0 and 60.0 mg/kg” of
treatment (Pevarello 6:44–45).
5. Pevarello teaches the “dosage depends on the age, weight,
conditions of the patient and on the administration route; for example, the
dosage adopted for oral administration to adult humans” (Pevarello 7:57–
59).
6. Selve teaches compounds “showing antinociceptive properties
for treating different types and symptoms of acute and chronic pain,
especially non neuropathic inflammatory pain” (Selve ¶ 19).
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7. Selve teaches “a pharmaceutical composition for the treatment
of different types and symptoms of acute and chronic pain, especially non
neuropathic inflammatory pain. This include chronic inflammatory pain e.g.
rheumatoid arthritis pain and/or secondary inflammatory osteoarthritic pain”
(Selve ¶ 20).
Principles of Law
“[T]he discovery or invention of a new use of a known process
machine, manufacture, composition of matter or material may be
patentable.” In re Hack, 245 F.2d 246, 248 (CCPA 1957).
Analysis
Appellant contends “Pevarello I does not describe a method of
treating inflammation, as presently claimed, but only provides for the use of
compounds of formula I as analgesic agents, that is, to treat pain” (Appeal
Br. 9). Appellant contends “Selve clearly describes that the formalin test is a
chemically-induced tonic pain model . . . . These features have resulted in
the formalin test being accepted as a valid model of persistent clinical
pain and not a test for inflammation” (id.). Appellant contends that
neither “Pevarello I and/or Selve described a method of treating
inflammation. Both references, on the contrary, describes method of treating
pain” (id. at 10).
The Examiner responds that “the target patient population of the
instant claims encompasses a patient with rheumatoid arthritis or
osteoarthritis and reducing or preventing inflammation is an intended result
of administering the claimed compound to the patient with an inflammatory
disorder such as rheumatoid arthritis or osteoarthritis” (Ans. 9).
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We agree with Appellant. The instant claims are drawn to treating
inflammation, not pain. The Examiner has not established that the prior art
treatment of pain necessarily results in treatment of inflammation, nor has
the Examiner established that patients with pain and patients with
inflammation necessarily represent the same patient population.
The Federal Circuit has recognized that treatment of one condition
does not necessarily render treatment of another condition obvious, stating
“a person of ordinary skill would not have drawn a connection between . . .
proposed treatment of autoimmune diseases in humans and a treatment for a
very different condition. This new use . . . would not have been readily
apparent as a likely successful application for a compound that might fight
autoimmune diseases.” Eli Lilly & Co. v. Teva Pharm. USA Inc., 619 F.3d
1329, 1338 (Fed. Cir. 2010).
In our previous Decision, we cited the inherency analysis in Perricone
v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005) as it applied to the
anticipation rejection. Here, the claims are now amended to include
limitations to treatment of particular types of inflammatory disease and are
therefore drawn to a new use of the elected compound of Formula I for
treatment of inflammation, instead of pain as described in the prior art of
Pevarello and Selve (see Claim 10; FF 1–7). And while Perricone found
application of a lotion composition to skin surfaces generally anticipated
application of the same composition for sunburn prevention because all skin
surfaces are susceptible to sun damage, Perricone found treatment of the
specific condition of skin that was already sunburned was not anticipated
because the prior art did not teach treatment of the sunburned skin condition.
Perricone, 432 F.3d at 1379–80.
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The same reasoning applies in the obviousness analysis here, where
neither Pevarello nor Selve teach or suggest treatment of inflammation with
the elected compound of Formula I. As Perricone teaches, “[n]ew uses of
old products or processes are indeed patentable subject matter.” Perricone,
432 F.3d at 1378. Here, the claims are drawn to a new use of the elected
compound of formula I in specific patient populations with specific
inflammatory diseases. While the Examiner attempts to draw a connection
between pain and inflammation, the Examiner has not established that there
is a necessary relationship between the two, because pain may result from
conditions other than inflammation and inflammation may not necessarily
cause pain to the patient.
We therefore conclude that the claims as written are drawn to a new
use of an old product, and no evidence is currently of record describing
treatment of inflammation with the elected compound of Formula I.
Conclusion of Law
The evidence of record does not support the Examiner’s finding that
Pevarello and Selve render the claims obvious.

B. Double Patenting over US RE40,259
Appellant contends
as discussed above, the presently claimed invention is not
directed to treating pain but rather is directed to treating
inflammation. Thus, for all of the reasons discussed with
regard to Pevarello I, Appellants respectfully submit that claims
41 and 45 of Pevarello II would not have rendered obvious the
presently claimed invention to one skilled in the art.
(Appeal Br. 16).
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The Examiner responds that “while the claims of ’259 patent do not
specifically recite rheumatoid arthritis and osteoarthritis as inflammatory
pain, rheumatoid arthritis and osteoarthritis are inflammatory pain as
evidenced by US2003/0171300 (abstract and [0020]), which is only cited
as evidentiary reference” (Ans. 15).
We agree with the Examiner. Claim 41 of US RE40,259 recites
administration of the same α-aminoamide compounds to patients for
treatment of “inflammatory pain,” while claim 45 recites “multiple sclerosis
pain.” We recognize that US RE40,259 does not specifically identify
osteoarthritis, for example, as a type of inflammation that causes pain, but
Selve establishes that the ordinary artisan would have recognized
osteoarthritis or rheumatoid arthritis patients as having inflammatory
conditions that cause pain (FF 6–7). Thus, the ordinary artisan, aware that
pain is comorbid with inflammation in osteoarthritis or rheumatoid arthritis
patients, would have found it inherent that treatment of the pain of these
patients with the same α-aminoamide drug disclosed in US RE40,259 would
inherently result in mitigation of the inflammation.
We recognize the tension with our reversal of the obviousness
rejection, but in that rejection, Pevarello did not even suggest treatment of
inflammatory pain, while US RE40,259 specifically recites treatment of
inflammatory pain. Therefore, unlike the patients in Pevarello, the patients
in US RE40,259 represent the same patient population treated with the same
drug at the same doses, and treatment of osteoarthritis pain or rheumatoid
arthritis pain would inherently treat the inflammation. We therefore find the
Examiner has therefore provided a reasonable prima facie case of
obviousness-type double patenting and has shifted the burden to Appellant
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to demonstrate that the method of US RE40,259, when applied to known
types of inflammatory pain as taught by Claim 41 and as evidenced by
Selve, would not have also treated inflammation.
Whether the rejection is based on “inherency” under 35 U.S.C.
§ 102, on “prima facie obviousness” under 35 U.S.C. § 103,
jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO’s inability to manufacture
products or to obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
DECISION
In summary:

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
10, 11, 14, 15 103(a) Pevarello, Selve 10, 11, 14, 15
10, 11, 14, 15 Double
Patenting
RE40,259 10, 11, 14,
15

Overall
Outcome
10, 11, 14,
15

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