Ex Parte Galer

Patent Trial and Appeal Board

Dec 31, 2012

10722737 (P.T.A.B. Dec. 31, 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.
10/722,737 11/25/2003 Bradley S. Galer BSG 021 US 7300
35812 7590 12/31/2012
GUY DONATIELLO
ENDO PHARMACEUTICALS
100 Endo Boulevard
CHADDS FORD, PA 19317
EXAMINER
ARNOLD, ERNST V
ART UNIT PAPER NUMBER
1613
MAIL DATE DELIVERY MODE
12/31/2012 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 BRADLEY S. GALER
__________

Appeal 2011-001679
Application 10/722,737
Technology Center 1600
__________

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

ELLURU, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to methods for treating neuropathically-induced negative
sensory phenomena in a patient. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.
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STATEMENT OF THE CASE
Claims 1-11 are on appeal. (App. Br. 1.) Claim 1 is representative
and reads as follows:
1. A method for treating neuropathically-induced negative sensory
phenomena in a patient comprising;
a) identifying a patient with neuropathically -induced negative
sensory phenomena;
b) identifying a locus of the neuropathically-induced negative
sensory phenomena; and
c) applying an anesthetic topically to the skin of the patient with
neuropathic negative sensory phenomena at or near the locus of
the negative sensory phenomena; whereby the neuropathically-
induced negative sensory phenomena in the patient is treated.

The Applied Prior Art
Harry Hind U.S. 5,411,738 May 2, 1995
Richard Wolicki U.S. 2004/010582 pub. May 27, 2004

Michael C. Rowbotham et al., The Relationship of Pain, Allodynia, and
Thermal Sensation in Post-Herpetic Neurlgia, 119 BRAIN 347 (1996)
(“Rowbotham”).

Medical Encyclopedia: Neuralgia,
http://www.nlm.nih.gov/medlineplus/ency/article/001407.htm, printed on
Jan 12, 2009. (“Medline Plus”)

Rejections
The Examiner rejected claims 1-11 under 35 U.S.C. § 102(b) as
anticipated by Hind. (Ans. 4-6).
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The Examiner rejected claims 1-11 under 35 U.S.C. § 103(a) as
obvious over Hind and Wolicki as evidenced by Medline Plus and
Rowbotham. (Id. at 7-8).

ISSUES
The anticipation rejection by Hind:
The Examiner finds that Hind discloses methods for treating nerve
injury such as post-herpetic neuralgia with topical application of lidocaine to
the skin “at the site of the pain.” (Ans. 4 (citing Hind Abstract and claims 1-
8)). The Examiner further finds that Hind teaches that post-herpetic
neuralgia patients nearly always have sensory deficit in the region of their
pain. (Ans. 9). The Examiner concludes that it is inherent in the method of
Hind that a patient is identified as having neuropathically induced negative
sensory phenomena (“NSP”) and the location of the NSP is identified. (Ans.
4). In support, the Examiner cites Rowbotham, which teaches that patients
with post-herpetic neuralgia demonstrate deficits in the perception of single
gentle touches, pinprick, heat and cold typically in the center of the painful
area. (Id.). The Examiner interprets “deficits in the perception of single
gentle touches” to mean numbness because the present application states that
numbness is a sensory deficit such as decreased ability to feel light touch
and that numbness is a neuropathically induced negative sensory
phenomena. (Id. at 4-5 (citing Spec. pp. 1, 3-4, ¶¶ [0002, 0011])). The
Examiner also cites as support Medline Plus, which identifies pain and
numbness of the affected skin area as symptoms of neuralgia, also known as
post-herpetic neuralgia. (Ans. 5 (citing Medline Plus Medical Encyclopedia,
pp. 1-2 of 4)). Thus, the Examiner concludes that by identifying a patient
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with post-herpetic neuralgia, where one of the symptoms is numbness,
performing the method of Hind, wherein application of lidocaine is applied
to the skin at the site of pain, inherently identifies and treats all symptoms of
neuralgia, including numbness. (Ans. 4-5).
Appellant contends that claims 1-11 are not inherently anticipated by
Hind as evidenced by Rowbotham and Medline Plus because the rejection
fails to establish all the elements of the claimed methods are “necessarily
present” in Hind’s disclosure. (App. Br. 4). Specifically, Appellant
contends that NSP or numbness are separate disease symptoms from pain
and may be entirely absent in patients suffering from post-herpetic neuralgia.
(Id. at 5-7). According to Appellant, all that Hind discloses about the
patients treated with the disclosed methods is that these patients had pain,
not neuropathically-induced NSP or numbness. (Id. at 7-8). Appellant
maintains that Hind is silent regarding the treatment of NSP or numbness
with the anesthetic compositions of claims 1-11 and that Hind does not
disclose the steps of identifying a patient with neuropathically-induced NSP,
identifying the locus of this phenomena and applying anesthetic to that
locus. (Id. at 9-10). Appellant further argues that the Medline Plus
reference relied upon to show inherency is deficient because, according to
Appellant, other prior art references teach that post-herpetic neuralgia can
occur without NSP or numbness and that patients with post-herpetic
neuralgia can have only painful symptoms. (Id. at 6).
The Examiner responds: “Appellant simply seems not to understand
or grasp the fact that a certain population of neuralgia patients experience
both pain and negative sensory phenomena and when a lidocaine patch is
applied to the locus of pain one inherently performs the instant method and
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treats both the pain and negative sensory phenomena.” (Ans. 12) (emphasis
added). As explained by the Examiner, Hind teaches that post-herpetic
neuralgia patients nearly always have a sensory deficit in the region
obtained, and thus, Hind includes those patients with sensory deficits. (Id. at
9 (citing Hind col. 1, ll. 28-30)). Further, “[t]he Examiner has shown that
pain [from neuralgia] and negative sensory phenomena are coextensive.”
(Ans. 9-10). Thus, it is inherent in the Hind method that a patient is
identified as having neuropathically induced NSP and the location is
identified because, as evidenced by Rowbotham, the pain and NSP are in the
same location, and performing the Hind method inherently treats all
symptoms of the disorder, including numbness. (Id. at 9).
The issue with respect to this rejection is:
Does the evidence of record support the Examiner’s conclusion that
Hind inherently discloses the claimed “identifying a patient with
neuropathically-induced negative sensory phenomena,” “identifying a locus
of neuropathically-induced negative sensory phenomena,” and “applying an
anesthetic topically to the skin of the patient with neuropathic negative
sensory phenomena at or near the locus of the negative sensory phenomena
whereby the neuropathically induced negative sensory phenomena in the
patient is treated?”
The obviousness rejection over Hind and Wolicki:
The Examiner finds that the only difference between the instant
application and Hind is that Hind does not expressly teach various benzoic
acid derivatives in its method and that this deficiency is cured by Wolicki.
(Ans. 8). The Examiner also finds that one of ordinary skill in the art would
have been motivated to add other benzoic acid derivatives, as suggested by
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Wolicki, to the Hind method because the art teaches the benzoic acid
derivatives to be equivalent in methods of treating neuropathy and the
expected result remains treatment of neuropathy. (Id.).
Appellant argues that claims 1-11 are not inherently obvious because:
(1) the Examiner failed to consider all the elements recited in the claims and
has ignored the actual recitations of the claims; (2) the Examiner has
improperly taken notice of a “universal fact;” (3) the obviousness rejection
improperly relies on the doctrine of inherent anticipation and references that
are not prior art; (4) the cited references fail to teach all the elements of the
claimed methods; (5) the present application embodies unexpected results
that are achieved by treating patients with anesthetics used in the claimed
methods; and (6) one of ordinary skill in the art would not be motivated to
perform the claimed methods based on the teachings of the cited references
or to reasonably expect success in doing so. (App. Br. 11).
The Examiner responds: With respect to Appellant’s arguments that
post-herpetic neuralgia pain can occur without NSP and that inherency is
improperly applied, the Examiner states this argument has been addressed by
the inherency discussion. (Ans. 11-12). The Examiner also notes that
Appellant makes an erroneous conclusion that the Hind patients only had
pain as a symptom, but that contention is not true because Hind does not
examine all symptoms such as heat, cold, gentle touch, etc. (Id.) In
addition, the Examiner responds that the Medline Plus reference is a bona
fide teaching in the art which aids in demonstrating that “[i]t is a universal
fact that patients with postherpetic neuralgia have numbness as a symptom .
. . .” (Id. at 13). The Examiner also notes that the critical date of extrinsic
evidence showing a “universal fact” need not antedate the filing date. (Id. at
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12). With respect to Appellant’s unexpected results argument, the Examine
responds that the present Specification contains only an anecdotal example,
as there is no experimental objective data for the Examiner to review, which
supports the Examiner’s position that pain and numbness are coextensive.
(Id. at 13). Lastly, with respect to Appellant’s argument that there is no
motivation and the claimed methods are more than the predictable use of
prior art elements according to their established functions, the Examiner
refers to the arguments provided in response to the other arguments. (Id.).
The issues with respect to this rejection are:
(i) Does the evidence of record support the Examiner’s conclusion
that the prior art references teach or suggest the disputed claim limitations,
i.e., “identifying a patient with neuropathically-induced negative sensory
phenomena,” “identifying a locus of the neuropathically-induced negative
sensory phenomena,” and “applying an anesthetic topically to the skin of the
patient with neuropathic negative sensory phenomena at or near the locus of
the negative sensory phenomena; whereby the neuropathically-induced
negative sensory phenomena in the patient is treated?”
(ii) Did the Examiner improperly rely on the Medline Plus
reference?
(iii) Does the evidence of record support the Examiner’s conclusion
that there is no objective evidence of unexpected results and a person of
ordinary skill in the art would have had a reasonable expectation of success
producing the claimed invention?
(iv) Has the Examiner provided reasoning with rationale
underpinning to support the conclusion of obviousness?

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Findings of Fact
1. Hind discloses methods and compositions for reducing never injury
pain associated with, for example, post-herpetic neuralgia with the
delivery of lidocaine. (Hind Abstract).
2. Hind discloses that post-herpetic neuralgia patients are able to localize
a limited area of skin as the source of their pain and that these
patients nearly always have a sensory deficit in the region obtained.
(Hind col. 1, ll. 28-30) (emphasis added).
3. Rowbotham discloses that “patients with PHN demonstrated deficits
in the perception of single gentle touches, pinprick, heat and cold
which were greatest in the centre of the painful area and faded toward
the boundary between involved and normal skin.” (Rowbotham, p.
347) (emphasis added).
4. Hind discloses a method comprising the application of an anesthetic to
a skin surface “at the site of said pain” for the relief of pain of a host
suffering from, for example, post-herpetic neuralgia. (Hind, claims 1-
8).
5. The present application discloses that neuropathically-induced NSP
include “numbness” and NSP is “manifested as the decreased ability
to feel light touch, pain, … warmth/heat, and coolness/cold.” (Spec.
pp. 3-4, ¶ [0011]).
6. Deficits in the perception of single gentle touch, as disclosed by
Rowbotham, means numbness pursuant to the present application,
which discloses that patients with neuropathy often develop
“symptoms of numbness such as a decreased ability to feel light touch,
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pain, … , warmth or heat, and cool or cold conditions in the area of
the never damage.” (Spec. p. 1, ¶ [0002]).
7. Medline Plus teaches that neuralgia symptoms include pain and
“numbness of the affected skin area.” (Medline Plus, pp. 1-2).
8. The methods of the present application comprise applying a
pharmaceutical compound to a patient suffering from neuropathic
NSP at a location near the sensory loss, and the preferred
pharmaceutical compound includes lidocaine. (Spec. pp. 2-3, ¶
[0009]).
9. Hind suggests that the method of applying lidocaine “at the site of
said pain” of post-herpetic neuralgia patients who indicate both pain
and sensory deficits treats both conditions. (Hind, entire document).
Principles of Law
“[T]he fact that a characteristic is a necessary feature or result of a
prior-art embodiment (that is itself sufficiently described and enabled) is
enough for inherent anticipation, even if that fact was unknown at the time
of the prior invention.” Toro Co. v. Deere & Co., 355 F.3d 1313, 1321 (Fed.
Cir. 2004).
In order for a reference to be proper for use in an obviousness
rejection under 35 U.S.C. § 103, the reference must be analogous art to the
claimed invention. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
The relevant inquiry is whether the Examiner has set forth “some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)
(cited with approval in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007)).
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“‘A reference may be said to teach away when a person of ordinary
skill, upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from
the path that was taken by the applicant.”’ Ricoh Co., Ltd. v. Quanta
Computer, Inc., 550 F.3d 1325, 1332 (Fed. Cir. 2008) (quoting In re Kahn,
441 F.3d 977, 990 (Fed. Cir. 2006)).
Analysis
35 U.S.C. § 102(b): Rejections of Claims 1-11 as anticipated by Hind
After considering the evidence and arguments, we agree with the
Examiner that Hind anticipates a method of treating neuropathically-induced
NSP, as recited in claim 1.
The present application defines “neuropathically induced negative
sensory phenomena” as including numbness and further defines numbness as
including “decreased ability to feel light touch.” (FF5, FF6).
Hind discloses treating post-herpetic patients who can identify a
limited area of skin as the source of their pain with application of lidocaine,
encompassed by the claimed “anesthetic” (FF1, FF8), to the skin “at the site
of the pain.” (FF2-FF4). Hind also discloses that post-herpetic neuralgia
patients nearly always have a sensory deficit in a limited area of skin
identified as the source of their pain. (FF2). Likewise, Rowbotham offers
further evidence that post-herpetic neuralgia patients have “deficits in the
perception of single gentle touches” in the center of the painful area. (FF3).
“[D]eficits in the perception of single gentle touch,” as disclosed by
Rowbotham, means numbness pursuant to the present application. (FF6).
Medline Plus also offers evidence that neuralgia symptoms include pain and
“numbness of the affected skin area.” (FF7).
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Therefore, we agree with the Examiner that practicing the Hind
method of treating neuralgia patients who also have a sensory deficit
necessarily “identif[ies] a patient with neuropathically-induced negative
sensory phenomena” (either by the patient or the treating individual). (Ans.
9-10). Appellant argues that even assuming a hypothetical patient that
suffers from both neuropathically-induced NSP and post herpetic neuralgia
in the same locus, pursuant to Hind, a treatment provider may be wholly
ignorant of the patient’s neuropathically induced NSP symptom or the
patient may not manifest the symptom of numbness. (Reply Br. 3-4).
Appellant’s argument lacks merit because in such a case the patient would
be able to identify himself or herself as having neuropathically induced NSP.
Performing this method also necessarily “identif[ies] a locus of the
neuropathically-induced negative sensory phenomena” because the patient
can identify the area of the skin as the source of pain and that is the same
location of the sensory deficit. (Ans. 9-10). Lastly, practicing this method
necessarily “appl[ies] an anesthetic topically to the skin of the patient with
neuropathic negative sensory phenomena at or near the locus of the negative
sensory phenomena, whereby the neuropathically-induced negative sensory
phenomena in the patient is treated” because Hind discloses application of
lidocaine at the site of the pain, which is coextensive with the sensory
deficit. (Ans. 9-10).
Appellant’s argument that NSP or numbness and pain are separate
disease symptoms and NSP or numbness are not “necessarily present” in
patients suffering from “post-herpetic neuralgia” and that the Examiner
conceded this point is misplaced. (App. Br. 9; Reply Br. 2). The crux of the
Examiner’s rejection is that a certain subpopulation of neuralgia patients
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experience both pain and NSP, as disclosed by Hind. When a lidocaine
patch is applied to the locus of pain of the Hind subpopulation it inherently
performs the instant method and treats both the pain and NSP. (Ans. 12).
Accordingly, for the reasons discussed supra, we conclude that Hind
inherently anticipates claim 1. We sustain the Examiner’s rejection of claim
1 as anticipated over that reference.
Claims 2-11 are not separately argued apart from claim 1, other than
Appellant stating the limitations of the independent claims. (App. Br. 10-
11). We, therefore, also sustain the rejections of claims 2-11 as anticipated
by Hind.
Conclusions of Law
(i) The evidence of record supports the Examiner’s conclusion that
claims 1 is anticipated by Hind. Claims 2-11 are not separately argued and
fall together with claim 1. (App. Br. 10-11). 37 C.F.R. § 41.37(c)(1)(iv).

35 U.S.C. § 103(a): Rejection of Claims 1-11as obvious over Hind and
Wolicki
The Examiner finds that claims 1- 11 are obvious over Hind and
Wolicki. (Ans. 8). Appellant argues that the Examiner has failed to
consider all the elements recited in the claims and has ignored the actual
recitations of the claims and that the cited references fail to teach or suggest
all the elements of the claimed methods. (App. Br. 11-12). We disagree for
the reasons discussed supra.
Next, we are not persuaded by the Appellant’s argument that the
Examiner improperly relied on the Medline Plus reference. (App. Br. 12).
First, we note that the Examiner cites MPEP § 2141.01 (Ans. 7), not MPEP
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§ 2124, as asserted by Appellant (App. Br. 12), in referring to the Medline
Plus reference. MPEP § 2141.01 allows the consideration of analogous prior
art in an obvious rejection, and Appellant does not argue that Medline Plus
is non-analogous to the present invention. Second, Appellant’s argument
that Medline Plus is contrary to art accepted dictionary definitions which
show that NSP or numbness may be entirely absent in patients suffering
from post-herpetic neuralgia is misplaced as discussed supra.
We are likewise not persuaded by Appellant’s argument that the
Examiner’s obviousness rejection improperly relies on inherent anticipation
and the Medline Plus is not “prior art” under 35 U.S.C. § 102. While the
Examiner states that he incorporates the inherent anticipation discussion into
the obviousness rejection, he did not conflate the two doctrines as alleged by
Appellant. (App. Br. 13-14). Appellant alleges that relying on inherency,
i.e., a hidden disclosure in a reference which would have been unknown and
unrecognized by a person of ordinary skill in the art, is improper in an
obviousness rejection. (App. Br. 15). However, the Examiner is not relying
on that which is unknown in the obviousness rejection. As discussed supra,
it was known that post-herpetic neuralgia patients are able to identify an area
of skin as the source of their pain and that these patients nearly always have
a sensory deficit in the same region. (FF2). Rowbotham also teaches that
post-herpetic neuralgia patients demonstrated deficits in the perception of
single touches in the centre of the painful area, i.e., the pain and sensory
deficits were located in the same area. (FF3). Furthermore, Medline Plus
teaches that neuralgia symptoms include pain and numbness of the affected
skin area. (FF7). It also was known to apply an anesthetic to a skin surface
“at the site of said pain” for the relief of pain of a host suffering from, for
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example, post-herpetic neuralgia. (FF4). Further, Hind suggests to a person
of ordinary skill in the art that the method of applying lidocaine “at the site
of said pain” of post-herpetic neuralgia patients who indicate both pain and
sensory deficits treats both conditions. (FF9). In addition, even assuming
Medline Plus is not prior art under 35 U.S.C. § 102 as alleged by Appellant
(App. Br. 15), the disclosure that neuralgia symptoms include pain and
“numbness of the affected skin area” is cumulative to Hind which itself
discloses that post-herpetic neuralgia patients nearly always have a sensory
deficit in the region of the skin identified as the source of the patient’s pain.
(FF2).
Appellant’s unexpected results argument lacks merit because, as the
Examiner explains, Appellant points to an anecdotal example that supports
the determination that pain and numbness are coextensive. (Ans. 13 (citing
Spec., p. ¶ [0018])). Appellant’s Reply Brief likewise does not refer to any
experimental objective data. (Reply Br. 4).
Lastly, Appellant argues that one of ordinary skill in the art would not
be motivated to perform the claimed methods, or reasonably expect success
on doing so. (App. Br. 17, Reply Br. 4). Appellant further argues that the
prior art references teach away from the claimed method of applying an
anesthetic to cause sensation to return or improve tactile response and
sensory loss in patients with neuropathically-induced NSP or numbness
because the references focus on the use of anesthetics to reduce, or
eliminate, sensations such as pain. (Id.). Thus, the Appellant contends that
the claimed methods are more than the predictable use of prior art elements
according to their established functions. (Id. at 18). We disagree.
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The U.S. Supreme Court has held that “[t]he obviousness analysis
cannot be confined by a formalistic conception of the words teaching,
suggestion, and motivation, or by overemphasis on the importance of
published articles and the explicit content of issued patents.” KSR, 550 U.S.
at 419. Instead, the relevant inquiry is whether the Examiner has set forth
“some articulated reasoning with some rational underpinning to support the
legal conclusion of obviousness.” KSR, 550 U.S. at 418. In addition, the
Court instructs that the simple substitution of one known element for another
is likely to be obvious if it does no more than yield predictable results. See
KSR, 550 U.S. at 417.
The Examiner combined Hind and Wolicki because Hind does not
expressly teach benzoic acid derivatives in the method. (Ans. 8). The
Examiner determined that a person of ordinary skill in the art would have
been motivated to add other benzoic acid derivatives, as suggested by
Wolicki, to the Hind method because the prior art teaches that benzoic acid
derivatives are equivalent in methods of treating neuropathy and the
expected result would be neuropathy treatment. (Id.) Thus, the Examiner
has provided an articulated reasoning with a rational underpinning to support
the obviousness determination and the claimed method is no more than a
substitution of known elements in the art to yield predictable results.
Furthermore, the prior art references do not teach away from the claimed
methods because they do not lead a person of ordinary skill in a direction
divergent from the path that was taken by the applicant. Ricoh, 550 F.3d at
1332 (citation omitted). In other words, the prior art references do not deter
a person of ordinary skill from applying lidocaine to a locus of the NSP to
treat the NSP.
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Conclusions of Law
(i) The evidence of record support the Examiner’s conclusion that
the prior art references teach or suggest the disputed claim limitations, i.e.,
“identifying a patient with neuropathically-induced negative sensory
phenomena,” “identifying a locus of the neuropathically-induced negative
sensory phenomena,” and “applying an anesthetic topically to the skin of the
patient with neuropathic negative sensory phenomena at or near the locus of
the negative sensory phenomena; whereby the neuropathically-induced
negative sensory phenomena in the patient is treated.”
(ii) The Examiner did not improperly rely on the Medline Plus
reference.
(iii) The evidence of record support the Examiner’s conclusion that
there is no objective evidence of unexpected results and a person of ordinary
skill in the art would have had a reasonable expectation of success producing
the claimed invention.
(iv) The Examiner provided reasoning with rationale underpinning
to support the conclusion of obviousness.
The evidence of record thus supports the Examiner’s conclusion that
Claim 1 is obvious over Hind and Wolicki. Claims 2-11 are not separately
argued and fall together with claim 1. (App. Br. 19). 37 C.F.R.
§ 41.37(c)(1)(iv).

SUMMARY
We affirm the rejection of claims 1-11 under 35 U.S.C. § 102(b) as
anticipated by Hind, and claims 1-11 under 35 U.S.C. § 103(a) as obvious
over Hind and Wolicki.
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CONCLUSION
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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