Christian Kersten et al.

Patent Trials and Appeals Board

Sep 17, 2020

2020001598 (P.T.A.B. Sep. 17, 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.
14/128,232 01/06/2014 Christian Kersten INVEN-32060.253 1034
72960 7590 09/17/2020
Casimir Jones, S.C.
2275 Deming Way Ste 310
Middleton, WI 53562
EXAMINER
FONTAINHAS, AURORA M
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
09/17/2020 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):
docketing@casimirjones.com
pto.correspondence@casimirjones.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte CHRISTIAN KERSTEN, MARTE GRØNLIE CAMERON, and
SVEIN MJÅLAND
____________

Appeal 2020-001598
Application 14/128,232
Technology Center 1600
____________

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

KATZ, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 seeks our review,2 under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 15 and 32–36, all of the pending claims
in the application. Claims 1–14, 16–31, 37 and 38 have been cancelled. We
have jurisdiction under 35 U.S.C. § 6(b). We REVERSE.

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 Sykehuset
Sørlandet HF. (See Appeal Br. 3.)
2 We consider the Specification dated December 20, 2013 (“Spec.”), Final
Office Action issued January 2, 2019 (“Final Act.”), the Appeal Brief filed
June 28, 2019 (“Appeal Br.”), the Examiner’s Answer issued October 23,
2019 (“Ans.”), and the Reply Brief filed December 19, 2019 (“Reply Br.”).
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INTRODUCTION
Appellant’s Specification provides methods of administering
epidermal growth factor receptor (“EGFR”) inhibitors to treat neuropathic
pain. (Spec. 9:10–14.) The Specification defines neuropathic pain as a
“complex, chronic pain state that usually is accompanied by tissue injury,”
that may include complex regional pain syndrome types I and II, trigeminal
neuralgia, phantom pain, and diabetic neuropathy. (Id. at 4:23–27.) The
Specification discloses that neuropathic pain responds poorly to standard
pain treatments, such as non-steroidal anti-inflammatory drugs or opioids,
and can lead to serious disability. (Id. at 1:32–2:14.)
The Specification discloses that activating mitogen-activated protein
kinase (“MAPK”)-signaling pathways is associated with neurological
diseases and neuropathic pain. (See id. at 8:29–30.) For example, EGF-
MAPK-signaling can be activated in neurons and glial cells in response to
injury or dysfunction. (See id. at 8:10–11.) The Specification discloses that
inhibiting EGFR may interrupt a negative feedback loop, thereby alleviating
symptoms from neurological disorders, especially neuropathic pain. (See id.
at 8:11–14.)
Appellant’s claim 1 recites3:
A method of treating a human subject that does not
have cancer or has not been previously treated for cancer
to relieve a neuropathic pain condition selected from the
group consisting of phantom limb pain, complex regional

3 Claim 1 has been modified by adding indentations.
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pain syndrome I, complex regional pain syndrome II,
trigeminal neuralgia, diabetic neuropathy, comprising

administering an agent that inhibits EGFR
polypeptide to a subject exhibiting symptoms of said
neuropathic pain condition,

wherein said subject is not receiving opioid
therapy and

said administering reduces, modulates or
eliminates said neuropathic pain condition and

said agent is selected from the group consisting of
cetuximab, panitumumab, afatinib, erlotinib, gefitinib,
lapatinib, and neratinib.

(Appeal Br. 10.)
The Examiner rejects the claims as anticipated by Gutstein.4 (See
Final Act. 3–4.) The Examiner also rejects the claims for nonstatutory
double patenting over claims 1–4, 6–8, 10–26, 28–30, and 32 of Application
15/270,525, now issued as U.S. Patent 10,611,844 B2. (See Final Act. 8–
10.)
ANALYSIS
Anticipation by Gutstein
The Examiner finds that Gutstein discloses a method of administering
a therapeutically effective amount of an EGFR modulator alone or in
combination with an opioid to treat chronic pain and reduce opioid

4 Gutstein, PCT Publication WO 2009/048947 A1, published April 16, 2009.
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tolerance. (See Ans. 3.) The Examiner finds further that Gutstein discloses
chronic pain includes neuropathic pain, such as, phantom limb pain,
complex regional pain syndrome, diabetic neuropathy, and trigeminal
neuralgia. (See id. at 4.) The Examiner finds that Gutstein discloses treating
“uniquely human diseases” and thus, implicitly supports treating humans.
(Id. at 3.) Finally, the Examiner finds that Gutstein discloses EGFR
inhibitors include anti-EGFR antibodies, such as cetuximab, panitumumab,
zalutumumab, nimotuzumab and matuzumab, and small molecule
antagonists, such as erlotinib and lapatinib. (See id.)
Appellant contends that Gutstein does not enable the use of EGFR
inhibitors to modulate or eliminate the specifically listed neuropathic pain
conditions in the absence of opioid therapy. (See Appeal Br. 4–5.)
According to Appellant, Gutstein does not enable one of ordinary skill in the
art to make the invention without undue experimentation in view of the
Wands factors. See In re Wands, 858 F.2d 731 (Fed. Cir. 1988). Applying
the factors, Appellant contends that: (1) the prior art recognizes that
neuropathic pain is notoriously difficult to treat in humans, (2) a high
quantity of experimentation would be needed to treat human neuropathic
pain; (3) Gutstein does not provide guidance of EGFR monotherapy for
treating neuropathic pain; and (4) Gutstein does not provide any dosage for
any EGFR inhibitor administered as monotherapy. (See Appeal Br. 7–8, see
also Reply Br. 7–15.)
Appellant contends further that Gutstein’s working Examples 1 and 3
show that administering EGFR inhibitor alone does not provide an analgesic
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effect. (Appeal Br. 6.) Appellant submits the Declaration of Dr. Michaelis,5
who states that Gutstein’s Example 3 indicates “that the EGFR inhibitor
gefitinib, when administered alone, is not analgesic in a neuropathic pain
model.” (Michaelis Decl. ¶ 4.) Dr. Michaelis states that a person of
ordinary skill in the art would have concluded that Gutstein’s negative
results for gefitinib indicates that “other EGFR inhibitors (such as
cetuximab, panitumumab, afatinib, erlotinib, lapatinib, and neratinib which
are specifically listed in the claims) . . . would not be effective to relieve
neuropathic pain in the absence of opioid therapy.” (Id. ¶ 6.) Accordingly,
Appellant argues that Gutstein does not sufficiently enable a person of
ordinary skill in the art to relieve neuropathic pain in the absence of opioid
therapy. (Reply Br. 15, citing Impax Labs., Inc. v. Aventis Pharm. Inc., 468
F.3d 1366, 1382 (Fed. Cir. 2006).)
The Examiner responds that Gutstein only disparages gefitinib, and
does not discourage using one of the other disclosed EGFR inhibitors to treat
neuropathic pain. (Ans. 6–7.) The Examiner finds that there is no evidence
in the art that the other EGFR inhibitors would not be capable of treating
neuropathic pain. (Id. at 7.) Accordingly, the Examiner finds that “only the
specific embodiment of gefitinib would be allowable over . . . Gutstein.”
(Id.)
We are persuaded by Appellant’s argument that Gutstein does not
disclose a method of administering an EGFR inhibitor without an opioid that
“reduces, modulates or eliminates” a neuropathic pain condition in a human

5 Declaration of Dr. Martin Michaelis dated August 7, 2018. (“Michaelis
Decl.”)
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subject. Because anticipation requires a showing of each limitation of a
claim in a single reference, we do not sustain the Examiner’s rejection as
discussed below. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.,
246 F.3d 1368, 1379 (Fed. Cir. 2001).
In Ben Venue Labs., our reviewing court found that claims directed to
a method of administering specific amounts of an anti-cancer agent were
anticipated by a prior art reference which disclosed the same method,
although without achieving an anti-cancer effect. See id. at 1378. Our
reviewing court held that the prior art anticipated the claims at issue despite
disclosing a “failed experiment.” See id. Accordingly, we do not agree with
Appellant that Gutstein’s Examples are dispositive on the issue of
enablement, merely because they show that gefitinib alone was ineffective in
treating neuropathic pain. We note that Appellant’s own examples include
two failed experiments of treating neuropathic pain with cetuximab (Case 1)
and panitumumab (Case 2), compared to two positive experiments of
administering cetuximab then gefitinib (Cases 2 and 3). (See Spec. 24:12–
26:2.) Despite these failed experiments, Appellant’s claims require
administering panitumumab or other non-tested compounds. (Contra
Michaelis Decl. ¶ 6.)
Nevertheless, we find that Gutstein simply does not teach each and
every element as set forth in the claim either expressly or inherently. See
Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631 (Fed. Cir. 1987).
Appellant’s claim 1 recites a particular result, namely “reduces, modulates,
or eliminates said neuropathic pain condition,” but Gutstein does not teach
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this result. Rather, Gutstein teaches that gefitinib, when administered alone,
is not analgesic in a neuropathic pain model.
In Ben Venue Labs., our reviewing court determined that the claims at
issue only required administering specific amounts of the therapeutic
compound and not achieving a particular result. 246 F.3d at 1378 (“Kris
enabled the performance of those steps even though he did not achieve a
favorable outcome, which was not a requirement of the claim.”) In contrast,
Appellant’s claim 1 recites a particular result, namely “reduces, modulates,
or eliminates said neuropathic pain condition.” (Appeal Br. 10.)
Accordingly, the particular result is a requirement of the claim, but that
particular result is not disclosed by the prior art. Cf. id. Furthermore, the
Examiner relies on Gutstein’s implicit teaching of treating humans, in the
absence of an explicit teaching or explanation of extrapolating a mouse
model (Examples 1 and 3) to the appropriate dose or regimen for a human.
Such implicit teaching does not meet the standard for anticipation. Because
the prior art does not disclose all of the claimed requirements, we do not
sustain the Examiner’s rejection of the claims under 35 U.S.C. § 102.

Obviousness-type Double Patenting
The Examiner provisionally rejects claims 15 and 32–36 under the
doctrine of obviousness-type double-patenting over claims 1–4, 6–8, 10–26,
28–30, and 32 of Application 15/270,525. (Final Act. 9.) After the
Examiner’s Answer in this appeal, Application 15/270,525 issued as U.S.
Patent 10,611,844 B2. If prosecution should continue in the current
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application, the Examiner may wish to revisit the rejection for obviousness-
type double-patenting over the issued claims of U.S. Patent 10,611,844 B2.
Appellant does not substantively address the double-patenting
rejection. (Appeal Br. 4.) Because the Examiner provisionally rejects the
claims on the ground of obviousness-type double-patenting, we conclude
that it is premature to address the provisional rejection. See Ex parte
Moncla, Appeal No. 2009-006448 (PTAB June 22, 2010). Accordingly, we
do not reach the Examiner’s obviousness-type double patenting rejection.

CONCLUSION
Upon consideration of the record and for the reasons given, we do not
sustain the Examiner’s anticipation rejection.
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
15, 32–36 102 Gutstein 15, 32–36
15, 32–36 Obviousness-type
double patenting
Claims 1–4, 6–8,
10–26, 28–30, 32
of Application No.
15/270,525
Not reached Not reached
Overall
Outcome
15, 32–36

REVERSED