Ex Parte Rauschkolb-Loffler et al

Patent Trial and Appeal Board

Dec 19, 2012

11089441 (P.T.A.B. Dec. 19, 2012)

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.
11/089,441 03/25/2005 Christine Rauschkolb-Loffler 6102-000025/US 1615
28997 7590 12/20/2012
HARNESS, DICKEY, & PIERCE, P.L.C
7700 Bonhomme, Suite 400
ST. LOUIS, MO 63105
EXAMINER
BRADLEY, CHRISTINA
ART UNIT PAPER NUMBER
1654
MAIL DATE DELIVERY MODE
12/20/2012 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte CHRISTINE RAUSCHKOLB-LOFFLER and BRIGITTE KOCH
__________

Appeal 2011-001383
Application 11/089,441
Technology Center 1600
__________

Before LORA M. GREEN, ERICA A. FRANKLIN, and
RAMA G. ELLURU, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods for preventing, alleviating and/or treating pain associated with
diabetic distal sensory polyneuropathy in a subject. The Patent Examiner
rejected the claims as anticipated, obvious, and on the ground of non-
statutory obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

Appeal 2011-001383
Application 11/089,441

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STATEMENT OF THE CASE
Claims 1, 23-32, 35, 36, 40, and 43-48 are on appeal.1 Claims 1, 30,
32, 40, and 48 are representative and read as follows:
1. A method for preventing, alleviating and/or treating pain
associated with diabetic distal sensory polyneuropathy in a subject, the
method comprising administering to the subject a therapeutically effective
amount of the compound (R)-2-acetamido-N-benzyl-3
methoxypropionamide or a pharmaceutically acceptable salt thereof.

30. A method for preventing, alleviating and/or treating pain
associated with diabetic distal sensory polyneuropathy in a subject, the
method comprising orally administering to the subject a pharmaceutical
composition comprising the compound (R)-2-acetamido-N -benzyl-3-
methoxypropionamide or a pharmaceutically acceptable salt thereof.

32. The method of claim 30, wherein the diabetic distal sensory
polyneuropathy is associated with Diabetes mellitus Type I.

40. The method of claim 30, wherein the compound contains at least
about 95% (w/w) R stereoisomer and at most about 5% (w/w) S isomer.

48. A method for alleviating and/or treating pain associated with
diabetic distal sensory polyneuropathy in a subject suffering from Diabetes
mellitus Type II, the method comprising administering to the subject the
compound (R)-2-acetamido-N-benzyl-3-methoxypropionamide, which
contains at least about 95% (w/w) R stereoisomer and at most about 5%
(w/w) S isomer, in an oral dosage amount of about 50 mg/day to about 600
mg/day for at least one week.

1 Claims 37 and 38 are also pending, but stand withdrawn from
consideration (App. Br. 5).
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The Examiner rejected the claims as follows:
• claims 1 and 43-46 under 35 U.S.C. §102(b) as anticipated by
Sommerville,2, 3 as evidenced by CAS Registry file 175481-36-4,4
Applicants’ Specification, and Hovinga;5
• claims 1, 23-26, 28-31, 35, 36, 40, and 43-46 under 35 U.S.C.
§102(b) as anticipated by Hovinga,6 as evidenced by CAS Registry file
175481-36-4, Applicants’ Specification;
• claims 1, 23-32, 35, 36, 40, and 43-48 under 35 U.S.C. § 103(a) as
unpatentable over Sommerville, as evidenced by CAS Registry file 175481-
36-4, Collins,7 Llewelyn,8 and Choi;9
• claims 1, 23-32, 36, 40, and 43-48 on the ground of non-statutory
obviousness-type double patenting as unpatentable over claims 1-7 of US

2Kenneth W. Somerville, Summary of the Schwarz Analysts Meeting,
SCHWARZ PHARMA’S NEUROLOGY PIPELINE CORPORATE COMMUNICATIONS,
12-21 (2/19/2003).
3 The Examiner withdrew the rejection of claims 23-32, 35, 36, 40, 47 and
48 under 35 U.S.C. §102(b) as anticipated by Sommerville. (See Ans. 25.)
4 CAS Registry file 175481-36-4
5 Collin A. Hovinga, SPM-927 Schwarz Pharma, 6 IDRUGS, NO. 6, 479-485
(2003).
6 The Examiner withdrew the rejection of claims 27, 32, 47 and 48 under 35
U.S.C. §102(b) as anticipated by Hovinga. (See Ans. 25.)
7 Sally L. Collins et al., Antidepressants and Anticonvulsants for Diabetic
Neuropathy and Postherpetic Neuralgia: A Quantitative Systemic Review,
20 J. PAIN AND SYMPTOM MANAGEMENT, 449-458 (2000).
8 J. Gareth Llewelyn, The Diabetic Neuropathies: Types, Diagnosis and
Management, 74 J. NEURAL NEUROSURG. PSYCHIATRY, ii15-ii19 (2003).
9 Daeock Choi et al., Synthesis and Anticonvulsant Activities of N-Benzyl-2-
acetamidopropionamide Derivatives, 39 J. MED. CHEM., 1907-1916 (1996).
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Patent No. 7, 416, 864 (Patent ‘864)10 in view of Choi, Collins, and
Llewelyn;
• claims 1, 23-32, 35, 36, 40, and 43-48 on the ground of non-
statutory obviousness-type double patenting as unpatentable over claims 1-8
of US Patent No. 7,427,601 (Patent ´601)11 in view of Choi, Collins, and
Llewelyn;
• claims 1, 23-32, 35, 36, 40, and 43-48 on the ground of non-
statutory obviousness-type double patenting as unpatentable over claims 1-
11 of US Patent No. 7, 718,161 (Patent ´161)12 (Application No.
12/212,864) in view of Choi, Collins, and Llewelyn;
• claims 1, 23-32, 35, 36, 40, and 43-48 on the ground of non-
statutory obviousness-type double patenting as unpatentable over claims 1-
12 of US Patent No. 7, 687,553 (Patent ´553)13 (Application No.
11/211,476) in view of Choi, Collins, and Llewelyn;
• claims 1, 23-32, 35, 36, 40, and 43-48 provisionally on the ground
of non-statutory obviousness-type double patenting as unpatentable over
claims 1-4, 14, 16-18, 20, 24-52 of copending US Patent Application No.
10/599,976 (Application ´976)14 in view of Choi, Collins, and Llewelyn;
• claims 1, 23-32, 35, 36, 40, and 43-48 provisionally on the ground
of non-statutory obviousness-type double patenting as unpatentable over
claims 2, 13-16, 22, 23, 26-33 and 36-40 of copending US Patent

10 US Patent No. 7,416,864 B2, issued to Thomas Stoehr, Aug. 26, 2008.
11 US Patent No. 7,427,601 issued to Thomas Stohr, Sep. 23, 2008 .
12 US Patent No. 7,718,161 B2 issued to Thomas Stohr, May 18, 2010.
13 US Patent No. 7,687,553 B2 issued to Beyreuther et al., Mar. 30, 2010.
14 US Application No. 10/599,976 by Dieter Scheller et al., filed on Aug. 7,
2008 now US Patent No. 8,008,351, issued on Aug. 30, 2011.
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Application No. 11/148,429 (Application ´429)15 in view of Choi, Collins,
and Llewelyn;
• claims 1, 23-32, 35, 36, 40, and 43-48 provisionally on the ground
of non-statutory obviousness-type double patenting as unpatentable over
claims 1, 8-17, 19-22 and 25-28 of copending US Patent Application No.
11/506,523 (Application ´523)16 in view of Choi, Collins, and Llewelyn;
• claims 1, 23-32, 35, 36, 40, and 43-48 provisionally on the ground
of non-statutory obviousness-type double patenting as unpatentable over
claims 1-47 of copending US Patent Application No. 12/063,956
(Application ´956)17 in view of Choi, Collins, and Llewelyn; and
• claims 1, 23-32, 35, 36, 40, and 43-48 provisionally on the ground
of non-statutory obviousness-type double patenting as unpatentable over
claims 1, 5-27 and 29-57 of copending US Patent Application No.
11/506,524 (Application ´524)18 in view of Choi, Collins, and Llewelyn.19

15 US Patent Application No. 11/148,429 by Thomas Stoehr et al., filed Jun.
9, 2005 now US Patent No. 7,820,857, issued on Oct. 26, 2010.
16 US Patent Application No. 11/506,523 by Bettina Beyreuther et al. filed
Aug. 18, 2006, now abandoned.
17 US Patent Application No.12/063,956, by Bettina Beyreuther et al., filed
Feb. 15, 2008.
18 US Patent Application No. 11/506,524 by Bettina Beyreuther et al., filed
Aug. 18, 2006, now abandoned.
19 The Examiner withdrew the provisional rejection of claims 1, 23-33, 36,
40 and 43-48 on the ground of non-statutory obviousness-type double
patenting as unpatentable over claims 1-28 of US Patent Application No.
11/506,577, Collins, Llewelyn and Choi; and the provisional rejection of
claims 1, 23-33, 36, 40 and 43-48 on the ground of non-statutory
obviousness-type double patenting as unpatentable over claims 1 and 3-23 of
US Patent Application No. 11/506,578, Collins, Llewelyn and Choi, because
these applications were abandoned. (Ans. 25-26.)
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ANTICIPATION
I. Anticipation by Sommerville
The Examiner found Sommerville taught a method of reducing pain in
diabetic neuropathy patients by administering harkoseride, which is an
alternative name for (R)-2-acetamido-N-benzyl-3 methoxypropionamide, as
evidence by CAS Registry file 175481-36-4. (Ans. 7.) The Examiner also
found that Sommerville disclosed a 10-week multicenter, randomized trial
wherein patients were administered up to 400 mg/day of harkoseride. (Id.)
The Examiner found that Sommerville disclosed the trial results indicated
that harkoseride is superior to placebo in reducing daily pain scores by
patients and that its side effects were comparable to the placebo. (Id.)
Additionally, the Examiner also found that Sommerville disclosed that the
patients in the trial had diabetic neuropathy, the reference did not expressly
disclose that their specific type of diabetic neuropathy was diabetic distal
sensory polyneuropathy. (Id.)
However, the Examiner found that the trial described in the instant
Specification is the same trial disclosed by Sommerville. (Id.) According to
the Examiner, Applicants stipulate that these clinical trials are one in the
same and involved patients with diabetic distal sensory polyneuropathy.
(Id.) The Examiner found that the Specification reports that “[s]ubjects had
clinically diagnosed pain attributed to diabetic distal sensory polyneuropathy
for 1-5 years and a diagnosis of diabetes mellitus Type I or Type II.
Subjects had at least moderate pain….” (Id. at 8) (quoting Spec. at 31, l. 32-
32, l. 3.) Therefore, the Examiner found that there is no difference between
Hovinga and the instantly claimed invention. (Id. at 8.)
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Regarding independent claims 1 and 30, Appellants do not contend
that the trial disclosed in Sommerville did not involve treating patients
having pain associated with diabetic distal sensory polyneuropathy by
administering to the patients a therapeutically effective amount of (R)-2-
acetamido-N-benzyl-3 methoxypropionamide. Rather, Appellants assert that
Sommerville itself fails to disclose that pain associated with diabetic
neuropathy in the patients of the clinical trial was more specifically pain
associated with diabetic distal sensory polyneuropathy. (See App. Br. 11-
13.) Appellants assert that “[i]f the ‘four corners’ of the document do not
disclose treatment for DDSP pain, then the public disclosure is limited to
treatment for DN pain.” (Reply Br. 2.) According to Appellants, “the use
of the current Application is improper and the Examiner is improperly using
a second document to ‘fill the gap’ in Sommerville and build a case of
anticipation.” (App. Br. 16.)
After considering the evidence and arguments, we agree with the
Examiner that Sommerville anticipates a method of treating pain associated
with diabetic distal sensory polyneuropathy, as recited in claim 1. The
Examiner provided a sound basis for the finding that the population of
patients treated in the trial disclosed by Sommerville included the population
of patients treated by the claimed method, i.e., the admission of Applicants.
Moreover, as Applicants describe in their Specification, “[p]ain
derived from a diabetic sensory neuropathy is the most common form of
diabetic neuropathy.” (Spec. 7.) Therefore, absent a disclosure in Hovinga
that the patients treated for pain associated with diabetic neuropathy
belonged to a subclass of diabetic neuropathy that excluded the most
common form of the disease, we find that a skilled artisan would have
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understood Hovinga inherently included the sub-genus of patients treated by
the claimed invention. This result is unchanged by Appellants’ assertion
that “the public disclosure is limited to treatment for [diabetic neuropathy]
pain,” (Reply Br. 2) (emphasis omitted) as diabetic distal sensory
polyneuropathy is a diabetic neuropathy.
Accordingly, we affirm the anticipation rejection of independent
claim 1. Appellants have not raised separate arguments for dependent
claims 43-46. Therefore, these claims fall with claim 1. See 37 C.F.R.
§ 41.37(c)(1)(vii).
II. Anticipation by Hovinga
The Examiner found that Hovinga taught a method of reducing pain in
diabetic neuropathy patients by administering SPM-927, which is an
alternative name for (R)-2-acetamido-N-benzyl-3 methoxypropionamide, as
evidence by CAS Registry file 175481-36-4. (Ans. 4.) The Examiner also
found that Hovinga disclosed a 10-week multicenter, randomized trial
wherein patients were administered up to 400 mg/day of SPM-927. (Id.)
The Examiner found that Hovinga disclosed the trial results indicated that
SPM-927 is superior to placebo in reducing daily pain scores by patients and
that its side effects were comparable to the placebo. (Id.) Additionally, the
Examiner found while Hovinga disclosed that the patients in the trial had
diabetic neuropathy, the reference did not expressly disclose that their
specific type of diabetic neuropathy was diabetic distal sensory
polyneuropathy. (Id.)
However, the Examiner found that the trial described in the instant
Specification is the same trial disclosed by Hovinga. (Id.) According to the
Examiner, Applicants stipulate that these clinical trials are one in the same
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and involved patients with diabetic distal sensory polyneuropathy. (Id.) The
Examiner found that the Specification reports that “[s]ubjects had clinically
diagnosed pain attributed to diabetic distal sensory polyneuropathy for 1-5
years and a diagnosis of diabetes mellitus Type I or Type II. Subjects had at
least moderate pain….” (Id. at 4-5)(quoting Spec. at 31, l. 32- 32, l. 3.)
Therefore, the Examiner found that there is no difference between Hovinga
and the instantly claimed invention. (Id. at 5.)
Appellants do not contend that the trial disclosed in Hovinga did not
involve treating patients having pain associated with diabetic distal sensory
polyneuropathy by administering to the patients a therapeutically effective
amount of (R)-2-acetamido-N-benzyl-3 methoxypropionamide. Rather,
Appellants assert Hovinga does not qualify as prior art. (App. Br. 20.)
According to Appellants: the clinical trial disclosed by Hovinga is the same
clinical trial reported in the Specification; this clinical trial constitutes a
reduction to practice of the present invention; to be considered prior art
under 35 U.S.C. § 102(a) the present invention must have occurred before
publication by Hovinga or before the confidential clinical trial could be
reported by Hovinga. (Id. 20-21) Appellants’ position is that the clinical
trial could not be reported by Hovinga before Applicant made the invention.
(Id. at 21.)
Hovinga was published in 2003. (Hovinga 479.) The instant
application was filed on March 25, 2005, and claims the benefit of U.S.
Provisional Application 60/556, 449, filed on March 26, 2004. (See
Amendment to Spec. 1.) As the Examiner correctly explained, “[i]f
Applicant wishes to swear-behind a prior art reference, an affidavit or
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declaration of prior invention under 37 CFR § 1.131 must be filed.” (Ans.
26.)
Further, Appellants assert that even if Hovinga is considered prior art,
“no disclosure directly relevant to the current Application is found in
Hovinga that is not merely cumulative over the disclosure of Sommerville.”
(App. Br. 21) According to Appellants, Hovinga does not anticipate the
claimed invention for the same reasons discussed regarding Sommerville.
(Id.)
Consequently, we disagree with Appellants for the same reasons
discussed regarding the anticipation rejection of Sommerville.
Accordingly, we affirm the Examiner’s anticipation rejection.

OBVIOUSNESS
The Examiner’s findings regarding Sommerville are as set forth for
the anticipation rejection, including finding that Sommerville did not
expressly teach that the patients treated for pain associated with diabetic
neuropathy was specifically pain associated with diabetic distal sensory
polyneuropathy (DDSP). (See Ans. 10.)
Additionally, the Examiner found that Llewelyn taught that DDSP is
the most common diabetic neuropathy and that treatment of DDSP involves
“strict glucose control from the time of diagnosis of [Diabetes mellitus] …
and the treatment and management of pain.” (Id.) The Examiner found that
Llewelyn taught that several drugs are approved for treatment of pain
associated with DDSP, including certain anticonvulsants, antidepressants,
and opioids. (Id. at 10-11.)
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The Examiner found that Collins taught that “antidepressants and
anticonvulsants clearly have an analgesic effect when compared with
placebo” for diabetic neuropathy and other types of neuropathic pain,
including three of the anticonvulsants recommended by Llewelyn. (Id. at
11.) Additionally, the Examiner found that Choi taught that harkoseride
(SPM 927) is an anticonvulsant. (Id.)
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to have
administered harkoseride to treat pain associated with DDSP because
Sommerville taught that it was effective to treat pain associated with the
diabetic neuropathy and Llewelyn taught that DDSP is the most common
subtype of diabetic neuropathy. (Id.) Further, the Examiner found that an
artisan would have been motivated to treat pain associated with DDSP with
harkoseride with a reasonable expectation of success because Llewelyn and
Collins taught that anticonvulsants can be used to treat pain associated with
diabetic neuropathy, including DDSP, and Choi taught that harkoseride is an
anticonvulsant, which Sommerville disclosed as being effective at treating
pain associated with diabetic neuropathy. (Id. at 11-12.)
Regarding claims independent claims 1 and 30, Appellants contend
that the “cited documents, alone or in combination, fail to teach or suggest
treating DDSP pain with SPM 927.” (App. Br. 21.) Specifically,
Appellants assert that “SPM 927 is not mentioned” in either Llewelyn or
Collins, but that these references instead disclose the use of the
anticonvulsants gabapentin and carbamazepine as treatment options. (Id. at
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22.) Additionally, Appellants submit Bril20 for its conclusion that “[o]ther
than carbamazepine and gabapentin, the proof for anti-epileptic drugs is
limited and none of the other anticonvulsants are suggested for treating
[diabetic polyneuropathy] at this time.” (Id. quoting Bril 195.) Therefore,
according to Appellants, a skilled artisan at the time of the invention would
not have been motivated to treat DDSP pain with SPM 927 and that the
weight of the evidence demonstrates that it was unpredictable whether SPM
927 would be effective for treating DDSP. (Id. at 23-24.)
This argument is not persuasive as the Examiner rejected the claims
over a combination including Sommerville and Appellants’ arguments have
not considered the teachings of all of the prior art references in combination.
Moreover, we are not persuaded that Bril provided evidence that only
carbamazepine and gabapentin were the only anticonvulsants suggested for
treatment of diabetic polyneuropathy at the time of the invention. (App. Br.
22.) Bril was published in 2001, two years before Sommerville and
Llewelyn. Thus, treatment options for pain associated with diabetic
neuropathy, including its subtype DDSP, had increased at the time of the
invention with Sommerville’s disclosure of the effectiveness of SPM 927,
along with the combined teachings of Llewelyn, Collins and Choi as set
forth by the Examiner. (See Ans. 11-12.)
Accordingly, we affirm the obviousness rejection of claims 1 and 30.
Regarding dependent claims 23, 27, 28, 32, and 40, Appellants further
assert that these claims “each recite additional limitations not disclosed,

20 Vera Bril, Status of Current Clinical Trials in Diabetic Polyneuropathy,
28 CAN. J. NEUROL. SCI., 191-198 (2001).

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taught or suggested in the art.” (App. Br. 25.) Appellants assert that they
“reiterate the entire arguments set forth above… in Sections 2.2-2.6, supra.”
(Id.)
We are not persuaded of nonobviousness by the arguments in these
sections as they assert that Sommerville did not expressly or inherently teach
the additional limitations of the claims without addressing the combined
teachings and suggestions of the prior art over which the Examiner made the
obviousness rejection. (See App. Br. 17-19.) Accordingly, we affirm the
obviousness rejection of claims 23, 27, 28, 32, and 40.
Regarding independent claim 48, Appellants further assert that
Sommerville did not disclose that “SPM contains at least 95% (w/w) R
stereoisomer and at most about 5% (w/w) S isomer;” or that “the subject has
Diabetes mellitus Type II.” (App. Br. 25.)
We are not persuaded by this argument. The Examiner found that
Sommerville taught the R stereoisomer of SPM 927, i.e., 100% R
stereoisomer, as evidenced by the CAS Registry file. (Ans. 13.) Appellants
have not provided evidence persuasively establishing otherwise. (See App.
Br. 25.) Additionally, the Examiner found that Sommerville disclosed that
the patients in the clinical trial had diabetic neuropathy associated with
Diabetes, which a skilled artisan would have understood included Type I and
Type II Diabetes mellitus. (Ans. 13.) Appellants have not provided
evidence persuasively establishing otherwise.
Accordingly, we affirm the obviousness rejection of claim 48.
Appellants have not raised separate arguments for claims 24-26, 29-
31, 33-36, and 43-47, therefore these claims fall with independent claims 1
and 30.
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OBVIOUSNESS-TYPE DOUBLE PATENTING
I. Claims 1, 23-33, 36, 40, and 43-48 over claims 1-7 of Patent ´864 in
view of Choi, Collins, and Llewelyn
The Examiner found that claims 1-7 of Patent ´864 recite a method of
treating tardive dyskinesia in a subject by administering (R)-2-acetamido-N-
benzyl-3-methoxypropionamide or a pharmaceutically acceptable salt
thereof. (Ans. 14.) However, the Examiner also found that the claims of
Patent ´864 did not recite a method of treating pain associated with DDSP
using (R)-2-acetamido-N-benzyl-3 methoxypropionamide. (Id. at 15.)
The Examiner found that: Choi taught that (R)-2-acetamido-N-benzyl-
3-methoxypropionamide is an anti-convulsant; Collins taught that
antidepressants and anticonvulsants, such as gabapentin, phenytoin and
carbamazepine, have an analgesic effect on diabetic neuropathy and other
types of neuropathic pain; and Llewelyn taught that diabetic distal
polyneuropathy is the most common diabetic neuropathy and that
antidepressants and anticonvulsants, such as gabapentin and carbamazepine,
are approved for treatment of pain associated with DDSP. (Id.)
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to have used (R)-
2-acetamido-N-benzyl-3-methoxypropionamide of Patent ´864 to treat
DDSP because the artisan would have been motivated by the teachings of
Collins and Llewelyn that the genus of diabetic neuropathy and the species
of DDSP can be treated by the same anticonvulsant drugs gabapentin and
carbamazepine, along with the teaching of Choi that SPM 927 is an
anticonvulsant, which is a class of drug that has been shown to be effective
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at alleviating pain associated with diabetic neuropathy and DDSP. (Id. at
16.)
Appellants contend that other than disclosing the compound SPM 927,
“no nexus is found between [Patent ´864] claims and the instant claims,
which relate to a method of treating a very different condition, namely pain
in DDSP.” (App. Br. 26.) Additionally, Appellants assert that the Examiner
has not established that Collins, Choi and Llewelyn provide any teaching or
suggestion that would supply such a nexus. (Id.)
We agree with Appellants. In particular, what is missing from the
combined references is a suggestion that the method of treating tardive
dyskinesia, as taught by the claims of Patent ´864, may also be useful to treat
DDSP pain. The prior art claims, even in view of the Choi, Collins and
Llewelyn, are patentably distinct from the rejected claims, with respect to
the medical condition being treated. See Eli Lilly & Co. v. Barr Labs., Inc.,
251 F.3d 955, 968 (Fed Cir. 2001).
Accordingly, we reverse the rejection.
II. Claims 1, 23-32, 35, 36, 40, and 43-48 over claims 1-8 of Patent ´601
in view of Choi, Collins, and Llewelyn
The Examiner found that claims 1-8 of Patent ´601 recite a method of
treating tremors in a subject by administering (R)-2-acetamido-N-benzyl-3-
methoxypropionamide or a pharmaceutically acceptable salt thereof. (Ans.
16.) However, the Examiner also found that the claims of Patent ´601 did
not recite a method of treating pain associated with DDSP using (R)-2-
acetamido-N-benzyl-3 methoxypropionamide. (Id. at 17.)
The Examiner´s findings regarding Choi, Collins and Llewelyn are set
forth above. According to the Examiner, it would have been obvious to a
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person of ordinary skill in the art at the time the invention was made to have
used (R)-2-acetamido-N-benzyl-3-methoxypropionamide of Patent ´601 to
treat DDSP for the reasons discussed regarding the rejection over Patent
´864. (Id.)
Appellants contend that other than disclosing the compound SPM 927,
“no nexus is found between [Patent ´601] claims and the instant claims,
which relate to a method of treating a very different condition, namely pain
in DDSP.” (App. Br. 27.) Additionally, Appellants assert that the Examiner
has not established that Collins, Choi and Llewelyn provide any teaching or
suggestion that would supply such a nexus. (Id.)
We agree with Appellants. In particular, what is missing from the
combined references is a suggestion that the method of treating tremors, as
taught by the claims of Patent ´601, may also be useful to treat DDSP pain.
The prior art claims, even in view of the Choi, Collins and Llewelyn, are
patentably distinct from the rejected claims, with respect to the medical
condition being treated.
Accordingly, we reverse the rejection.
III. Claims 1, 23-32, 35, 36, 40, and 43-48 over claims 1-11 of Patent
´161 (Application ´864) in view of Choi, Collins, and Llewelyn
The Examiner found that claims 1-11 of Patent ´161 recite a method
of treating motoneuron disorder in a subject by administering lacosamide, an
alternate name for (R)-2-acetamido-N-benzyl-3-methoxypropionamide.
(Ans. 17.) However, the Examiner also found that the claims of Patent ´161
did not recite a method of treating pain associated with DDSP using (R)-2-
acetamido-N-benzyl-3 methoxypropionamide. (Id. at 18.)
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The Examiner´s findings regarding Choi, Collins and Llewelyn are set
forth above. According to the Examiner, it would have been obvious to a
person of ordinary skill in the art at the time the invention was made to have
used (R)-2-acetamido-N-benzyl-3-methoxypropionamide of Patent ´161 to
treat DDSP for the reasons discussed regarding the rejection over Patent
´864. (Id.)
Here again, we find that the Examiner´s rejection is missing a
suggestion that the method of treating motoneuron, as taught by the claims
of Patent ´864, may also be useful to treat DDSP pain. The prior art claims,
even in view of the Choi, Collins and Llewelyn, are patentably distinct from
the rejected claims, with respect to the medical condition being treated.
Accordingly, we reverse the rejection.
IV. Claims 1, 23-32, 35, 36, 40, and 43-48 over claims 1-12 of Patent
´553 (Application ´476) in view of Choi, Collins, and Llewelyn
The Examiner found that claim 1 of Patent ´553 recite a method of
treating bone cancer pain and/or chemotherapy-induced pain in a subject by
administering (R)-2-acetamido-N-benzyl-3-methoxypropionamide. (Ans.
18-19.) The Examiner also found that the pain is neuropathic. (Id. at 19.)
However, the Examiner also found that the claims of Patent ´553 did not
recite a method of treating pain associated with DDSP using (R)-2-
acetamido-N-benzyl-3 methoxypropionamide. (Id.)
The Examiner´s findings regarding Choi, Collins and Llewelyn are set
forth above. According to the Examiner, it would have been obvious to a
person of ordinary skill in the art at the time the invention was made to have
used (R)-2-acetamido-N-benzyl-3-methoxypropionamide of Patent ´553 to
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treat DDSP for the reasons discussed regarding the rejection over Patent
´864. (Id.)
Here again, we find that the Examiner´s rejection is missing a
suggestion that the method of treating bone cancer pain and/or
chemotherapy-induced pain, as taught by the claims of Patent ´553, may also
be useful to treat DDSP pain. The teaching that the cancer and/or
chemotherapy pain is neuropathic is not a teaching that the pain is related to
diabetic neuropathy pain or more specifically DDSP pain. The prior art
claims, even in view of the Choi, Collins and Llewelyn, are patentably
distinct from the rejected claims, with respect to the medical condition being
treated.
Accordingly, we reverse the rejection.
V. Claims 1, 23-32, 35, 36, 40, and 43-48 provisionally over claims 1-4,
14, 16-18, 20, 24-52 of Application ´976 in view of Choi, Collins, and
Llewelyn
The Examiner found that claim 52 of Application ´976 recites a
method of treating cortical spreading depression in a subject by
administering (R)-2-acetamido-N-benzyl-3-methoxypropionamide. (Ans.
20.) However, the Examiner also found that the claims of Application ´976
did not recite a method of treating pain associated with DDSP using (R)-2-
acetamido-N-benzyl-3 methoxypropionamide. (Id.)
The Examiner’s findings regarding Choi, Collins and Llewelyn are set
forth above. According to the Examiner, it would have been obvious to a
person of ordinary skill in the art at the time the invention was made to have
used (R)-2-acetamido-N-benzyl-3-methoxypropionamide of Application
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´976 to treat DDSP for the reasons discussed regarding the rejection over
Patent ´864. (Id.)
Application ´976 issued as US Patent No. 8, 008, 351 on August 30,
2011. Accordingly, the rejection is no longer provisional.
We find that the Examiner´s rejection is missing a suggestion that the
method of treating cortical spreading depression, as taught by the claims of
Patent ´351, may also be useful to treat DDSP pain. The prior art claims,
even in view of the Choi, Collins and Llewelyn, are patentably distinct from
the rejected claims, with respect to the medical condition being treated.
Accordingly, we reverse the rejection.
VI. Claims 1, 23-32, 35, 36, 40, and 43-48 provisionally over claims 2,
13-16, 22, 23, 26-33 and 36-40 of Application ´429 in view of Choi, Collins,
and Llewelyn
The Examiner found that claim 40 of Application ´429 recites a
method of treating a neuropathic trigeminal pain in a subject by
administering (R)-2-acetamido-N-benzyl-3-methoxypropionamide. (Ans.
21.) However, the Examiner also found that the claims of Application ´976
did not recite a method of treating pain associated with DDSP using (R)-2-
acetamido-N-benzyl-3 methoxypropionamide. (Id.)
The Examiner’s findings regarding Choi, Collins and Llewelyn are set
forth above. According to the Examiner, it would have been obvious to a
person of ordinary skill in the art at the time the invention was made to have
used (R)-2-acetamido-N-benzyl-3-methoxypropionamide of Application
´429 to treat DDSP for the reasons discussed regarding the rejection over
Patent ´864. (Id.)
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Application ´429 issued as US Patent No. 7,820,857 on October 26,
2010. Accordingly, the rejection is no longer provisional.
We find that the Examiner´s rejection is missing a suggestion that the
method of treating neuropathic trigeminal pain, as taught by the claims of
Patent ´857, may also be useful to treat DDSP pain. While the condition
treated is a neuropathic pain, there is no teaching or suggestion that this pain
is related to diabetic neuropathy pain or more specifically DDSP pain. The
prior art claims, even in view of the Choi, Collins and Llewelyn, are
patentably distinct from the rejected claims, with respect to the medical
condition being treated.
Accordingly, we reverse the rejection.
VII. Claims 1, 23-32, 35, 36, 40, and 43-48 provisionally over claims 1, 8-
17, 19-22 and 25-28 of Application ´523 in view of Choi, Collins, and
Llewelyn
Application ´523 was abandoned. (Notice of Abandonment, dated
June, 7, 2011.) Accordingly, this rejection is dismissed as moot.
VIII. Claims 1, 23-32, 35, 36, 40, and 43-48 provisionally over claims 1-47
of Application ´956 in view of Choi, Collins, and Llewelyn
The Examiner found that the claim 27 of Application ´956 recites a
method of treating non-inflammatory musculoskeletal pain, osteoarthritic
pain, fibromyalgia pain syndrome, back pain or osteoarthritis in a subject by
administering (R)-2-acetamido-N-benzyl-3-methoxypropionamide. (Ans.
23.) However, the Examiner also found that Application ´956 did not recite
a method of treating pain associated with DDSP using (R)-2-acetamido-N-
benzyl-3 methoxypropionamide. (Id.)
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The Examiner’s findings regarding Choi, Collins and Llewelyn are set
forth above. According to the Examiner, it would have been obvious to a
person of ordinary skill in the art at the time the invention was made to have
used (R)-2-acetamido-N-benzyl-3-methoxypropionamide of Application
´956 to treat DDSP for the reasons discussed regarding the rejection over
Patent ´864. (Id. at 24.)
We find that the Examiner’s rejection is missing a suggestion that the
method of treating non-inflammatory musculoskeletal pain, as taught by the
claims of Application ´956, may also be useful to treat DDSP pain. The
prior art claims, even in view of the Choi, Collins and Llewelyn, are
patentably distinct from the rejected claims, with respect to the medical
condition being treated.
Accordingly, we reverse the rejection.
IX. Claims 1, 23-32, 35, 36, 40, and 43-48 provisionally over claims 1, 5-
27 and 29-57 of Application ´524 in view of Choi, Collins, and Llewelyn
Application ´524 was abandoned. (Notice of Abandonment, dated May 31,
2012.) Accordingly, this rejection is dismissed as moot.
SUMMARY
We affirm the anticipation and obviousness rejections;
we reverse the provisional and non-provisional obviousness-type
double patenting rejections that have not otherwise been dismissed.

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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

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