Ex Parte Gjorstrup

Patent Trial and Appeal Board

Oct 13, 2016

12287712 (P.T.A.B. Oct. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/287,712 10/10/2008
20350 7590 10/17/2016
KILPATRICK TOWNSEND & STOCKTON LLP
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
Per Gjorstrup
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
072244-1303 9684
EXAMINER
BASQUILL, SEAN M
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
10/17/2016 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):
ipefiling@kilpatricktownsend.com
j lhice@kilpatrick.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PER GJORSTRUP
Appeal2014-007706
Application 12/287,712
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
of treating dry eye. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
"Dry eye, or keratoconjunctivitis sicca, is a common ophthalmological
disorder that affects a significant proportion of the worldwide population.
Some of these individuals suffer from Sjogren's disease" (Spec. 2: 18-20).
"Individuals afflicted with the systemic autoimmune disease known as
1 Appellant identifies the Real Party in Interest as C.T. Resolve
Sarl (see App. Br. 3).
Appeal2014-007706
Application 12/287,712
Sjogren's syndrome typically suffer severe dry eye. In this disease,
inflammation of the lacrimal gland impairs normal secretory processes"
(Spec. 2:27-29). "Prior therapies for dry eye have included both palliative
agents, such as artificial tear formulations, and drugs, such as topical
steroids" (Spec. 3:1-2).
The Claims
Claims 1, 6-9 and 13 are on appeal. Independent claim 1 is
representative and reads as follows:
1. A method of treating dry eye in a patient comprising
administering to said patient a compound of formula 43:
wherein Re, Rf, Ri, Rs and R9 are each hydrogen;
E is hydroxyl or alkoxy; and
Rs is CH2CH2CH2;
or a pharmaceutically acceptable salt thereof.
App. Br. 21 (Claims Appendix).
The Issue
0 OR,)l
R5 E
The Examiner rejected claims 1, 6-9, and 13 under 35 U.S.C. § 103(a)
as obvious over Petasis,2 Pflugfelder,3 and Gamache4 (Final Act. 5---6).
2 Petasis, N., US 7,582,785 B2, issued Sept. 1, 2009 ("Petasis").
3 Pflugfelder et al., The Diagnosis and Management of Dry Eye, 19
CORNEA 644---649 (2000) ("Pflugfelder").
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The Examiner finds that Petasis teaches "Compound 29 is effective in
treating diseases or conditions associated with inflammation or
inflammatory response" (Ans. 6). The Examiner acknowledges that "Petasis
does not specifically list dry eye as among the disorders treatable by the
administration of compounds of Formula 29" (Id.).
The Examiner finds that "Gamache indicates that inflammatory
responses contribute to dry eye syndrome" and that "Pflugfelder indicates
both that the loss of anti-inflammatory environment in the eye leads to dry
eye disease ... and that treatment with anti-inflammatory agents improves
both irritation symptoms and ocular surface abnormalities associated with
the disease" (Id.).
(Id.).
The Examiner finds that because the compounds of Petasis
are known to act as anti-inflammatory agents, and both
Gamache and Pflugfelder teach the skilled artisan that
administration of anti-inflammatory agents improves both
symptoms of and ocular surface disruptions associated with dry
eye disease, it would have been prima facie obvious for the
skilled artisan to use the compounds of the instant invention to
treat dry eye disease
The issue with respect to this rejection is: Does the evidence support
the Examiner's conclusion that Petasis, Gamache, and Pflugfelder render
claim 1 obvious?
4 Gamache et al., US 6,645,978 Bl, issued Nov. 11, 2003
("Gamache").
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Application 12/287,712
Findings of Fact
1. Petasis teaches "compounds, compositions and methods using
trihydroxy polyunsaturated eicosanoid derivatives for the prevention,
amelioration and treatment of a variety of diseases or conditions associated
with inflammation or inflammatory response" (Petasis 1 :26-30).
2. Petasis teaches the "present invention provides compounds of
general formulas 29 ...
29
11
wherein: A is hydroxy, alkoxy ... Ra and Rb are independently selected
from the group consisting of hydrogen" (Spec. 30:4---62).
3. Petasis teaches therapeutic uses of the compounds of the
invention include "diseases or conditions associated with inflammation or
inflammatory response" (Petasis 33: 57---61) and specifically claims
compound 29 (see Petasis 44:25--45, claim 9).
4. Gamache teaches that "inflammatory processes may contribute
to ocular surface abnormalities in dry eye conditions .... [M]arkers of
inflammation on the ocular surface of patients with Sj6gren's [sic] and non-
Sjogren's keratoconjunctivitis sicca has been reported ... and anti-
inflammatory steroids have demonstrated therapeutic efficacy in dry eye
patients" (Gamache 4:22-39).
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Application 12/287,712
5. Pflugfelder teaches "[i]nflammation may represent another
important causative factor for KCS [keratoconjunctivitis sicca]. Decreased
aqueous tear production and tear clearance leads to chronic inflammation of
the ocular surface" (Pflugfelder 646, col. 2).
6. Pflugfelder teaches that "[c]onsistent with an immunologic
mechanism for development of KCS, antiinflammatory therapy has been
reported to improve both irritation symptoms and ocular surface disease.
Our center has reported that topically applied corticosteroids remarkably
improve the irritation symptoms and ocular surface signs of KCS"
(Pflugfelder 648, col. 1 ).
7. The Specification teaches, in Example 1, that "both compound
X and its analog, compound Z, in a concentration-dependent manner
suppress hypertonicity-induced release of the inflammatory mediators IL-6"
(Spec. 93 :25-27).
8. The Specification teaches, in Example 2, that "compounds V
and W protected against goblet cell loss and also improved corneal barrier
function in mice exposed to desiccating stress" (Spec. 95:8-9).
9. The Specification teaches, in Example 3, that "[c]ompounds V
and W blocked the over-expression of Arginase I and COX-2, two key pro-
inflammatory enzymes. The results suggest that this class of compounds has
therapeutic potential in the treatment of DE [(dry eye)]" (Spec. 96:1-3).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
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Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 5---6; FF 1---6) and agree that the
claims are rendered obvious by Petasis, Gamache, and Pflugfelder. We
address Appellant's arguments below.
Appellant contends that:
Only the present Appellant teaches that the short chain
compounds contemplated by the present claims (i.e.,
compounds having a 15 carbon backbone, rather than a 20
carbon backbone, as contemplated in the art) are surprisingly
effective for the treatment of dry eye. Appellant's discovery of
the efficacy of such compounds makes for a simpler synthesis
of the active agent, resulting in a less expensive active agent.
(App. Br. 12).
We find this argument unpersuasive because there is no disclosure of
any unexpected results in the Specification (FF 7-9). While the Weiss
Declaration5 states the results are "surprising", the Declaration provides only
opinion evidence that the results would have been unexpected relative to the
anti-inflammatory compound 29 disclosed and claimed by Petasis. That is,
Dr. Weiss states that "[ s ]uch surprising effects of the compounds embraced
by the present claims include protection against goblet cell loss and
reduction of corneal epithelial barrier disruption" (Weiss Dec. i-f 10).
However, there is no comparison of the effects of the claimed compounds
with the closest prior art of compound 29 of Petasis. See In re Baxter
Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) ("when unexpected
5 Declaration of Dr. Sidney L. Weiss, dated May 28, 2013.
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Application 12/287,712
results are used as evidence of nonobviousness, the results must be shown to
be unexpected compared with the closest prior art.").
Equally important, the Weiss Declaration lacks evidence
demonstrating that the effects shown of protection against goblet cell loss
and reduction of corneal epithelial barrier disruption are not general
properties that would be possessed by any anti-inflammatory treatment of
dry eye. That is, there is no evidence that these results represent anything
other than the expected result of administering an anti-inflammatory
compound to a patient with dry eye.
Appellant contends that the "Examiner cannot establish, without
relying on improper hindsight analysis (having benefit of the present
application) that one of ordinary skill would be motivated to make the very
specific modifications to the cited references" (App. Br. 13).
We are not persuaded. While we are fully aware that hindsight bias
may plague determinations of obviousness, Graham v. John Deere Co., 383
U.S. 1, 36 (1966), we are also mindful that the Supreme Court has clearly
stated that the "combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results." KSR, 550 U.S. at 416. In the instant case, the Examiner has
established that inflammation contributes to dry eye (FF 4 and 5), that anti-
inflammatory compounds are used for treatment (FF 4 and 6), and that
compound 29 is an anti-inflammatory compound (FF 1 and 3). We agree
with the Examiner that the ordinary artisan would have found it obvious to
treat a disease caused by inflammation with an anti-inflammatory compound
(see Ans. 6).
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Appellant contends that
Petasis does not disclose the compounds of the instant claims as
useful for treating inflammatory conditions. Instead, Petasis
discloses that compounds having a C-20 backbone may be
useful for [] treating inflammatory conditions, whereas the
present claims specifically require the use of defined
compounds having a C-15 backbone for a much more specific
indication, treatment of dry eye.
(App. Br. 14).
We are not persuaded. Compound 29 has a C-15 backbone as argued
by Appellant, and Petasis specifically teaches that compound 29 is a
compound of the invention (FF 2), even specifically claiming compound 29
(FF 3). Petasis further teaches that compounds of the Petasis invention have
anti-inflammatory biological activity (FF 1 and 3). Thus, we agree with the
Examiner that "a skilled artisan would clearly conclude that Petasis teaches
that the compounds of formula 29 are indeed anti-inflammatory agents
within the meaning of the invention disclosed by Petasis" (Ans. 4).
We recognize, but find unpersuasive, Appellant's argument that "it is
incumbent on the Examiner to identify where in the art any motivation is
provided to use the particular compounds required by the claims for
administration to the eye for the treatment of dry eye" (App. Br. 15; cf App.
Br. 16). In KSR, the Supreme Court rejected the rigid application of the
teaching, suggestion, and motivation test, stating that "[ w ]hen a work is
available in one field of endeavor, design incentives and other market forces
can prompt variations of it, either in the same field or a different one. If a
person of ordinary skill can implement a predictable variation, § 103 likely
bars its patentability" KSR, 550 U.S. at 417. We find that the ordinary
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artisan would have predictably applied the Petasis anti-inflammatory
compound 29 to diseases where inflammation is a contributing cause
including dry eye (FF 1---6).
Appellant contends that the "inventors identified the particular
combination of a specific indication and a very limited number of
compounds for treatment thereof, as required by the present claims, from
among hundreds or thousands of possible medicament/ disease combinations
in an unpredictable field (drug development)" (App. Br. 15).
We are not persuaded. It is well settled that it is a matter of
obviousness for one of ordinary skill in the art to select a particular
component from among many disclosed by the prior art as long as it is
taught that the selection will result in the disclosed effect, even when the
possible selections are numerous. Merck & Co., Inc. v. Biocraft Labs., Inc.,
874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed.
Cir. 1985). Indeed, Appellant's own Specification supports this position by
reciting a genus of compounds much larger than that encompassed by
compound 29 for treatment of dry eye (see Spec. 8:24--13:4) even teaching
that the ordinary artisan, when taught compounds such as compound 29,
would have further recognized that:
compounds useful in this invention are compounds that are
chemically similar variants to any of the compounds of formula
A or formulae 1-49 set forth above. The term "chemically
similar variants" includes, but is not limited to, replacement of
various moieties with known biosteres; replacement of the end
groups of one of the compounds above with a corresponding
end group of any other compound above, modification of the
orientation of any double bond in a compound, the replacement
of any double bond with a triple bond in any compound, and the
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replacement of one or more substituents present in one of the
compounds above with a corresponding substituent of any other
compound.
(Spec. 39: 10---18).
Appellant contends that "there still would be no reasonable
expectation that such compounds would have such added benefits as
protecting against goblet cell loss and reducing corneal epithelial barrier
disruption as the compounds embraced by the present claims were found to
do" (App. Br. 17-18).
We are not persuaded because Appellant has not established that
goblet cell loss and reducing corneal epithelial barrier disruption do not
necessarily result from the administration of any anti-inflammatory
compound. The comparisons in Examples 13 were with control groups
treated only with vehicle, and no comparison was made with other anti-
inflammatory compounds. \Vhile the \Veiss Declaration states that these
results are surprising (see Weiss Dec. i-f 11 ), the Declaration provides no
evidence that other anti-inflammatory compounds would not inherently have
had these properties. Indeed, the Declaration does not even state that other
anti-inflammatory compounds would not inherently result in the benefits
identified. See In re Best, 562 F.2d 1252, 1254--55 (CCPA 1977).
Specific to the reasonable expectation of success, Petasis teaches the
compounds are anti-inflammatory (FF 1-3) and Gamache and Pflugfelder
teach treatment of the anti-inflammatory condition dry eye with anti-
inflammatory compounds (FF 4--6). We therefore conclude that the ordinary
artisan would have found a reasonable expectation of success in applying
this combination in practical use. Kubin stated that, "[r]esponding to
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concerns about uncertainty in the prior art influencing the purported success
of the claimed combination, this court [in 0 'Farr ell] stated: ' [ o ]bviousness
does not require absolute predictability of success ... all that is required is a
reasonable expectation of success."' In re Kubin, 561F.3d1351, 1360 (Fed.
Cir. 2009) (citing In re 0 'Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988)).
Appellant contends that "that there are many anti-inflammatory agents
approved for a vast array of inflammatory diseases other than dry eye
(including ocular anti-inflammatory agents approved for ophthalmic
diseases) that are not approved or used for treatment of dry eye" (App. Br.
19). Appellant and the Weiss Declaration further point to Xibrom and
contend that the "FDA label further warns against use of Xibrom for more
than 14 days-which is inconsistent with its use for dry eye (a chronic
disease, for which standard dry eye treatment would be continued well over
the limited administration period of 14 days)." (App. Br. 19; cf Weiss Dec.
ii 13).
We find this argument unpersuasive because Appellant's own
Specification teaches that corticosteroids, known anti-inflammatory agents,
are used for treatment of dry eye (Spec. 3: 1-7), even though chronic use is
undesirable (Spec 3:20-22). Moreover, that Xibrom is not approved for dry
eye, without evidence that dry eye was a requested use and that FDA denied
approval for dry eye, simply evidences that when a drug manufacturer
applies for FDA approval, they apply for limited conditions based on their
efficacy evidence. That is, the manufacturer may not have requested
approval of Xibrom for dry eye. This does not teach away or otherwise
discourage the use of compound 29 in anti-inflammatory conditions such as
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dry eye as suggested by the combination of Petasis, Gamache, and
Pflugfelder (FF 1---6). See Purdue Pharma L.P. v. Endo Pharmaceuticals
Inc., 438 F.3d 1123, 1134 (Fed. Cir. 2006) ("[T]he quantum of proof
necessary for FDA approval is significantly higher than that required by the
PTO.").
We further note that claim 1 does not require any duration of
administration, so the argument regarding chronic administration for more
than 14 days does not reflect any limitation in claim 1 and claim 1
encompasses shorter duration administration of the anti-inflammatory
compound. See In re Self, 671F.2d1344, 1348 (CCPA 1982)
("[A]ppellant's arguments fail from the outset because ... they are not based
on limitations appearing in the claims.")
Conclusion of Law
The evidence supports the Examiner's conclusion that Petasis,
Gamache, and Pflugfelder render claim 1 obvious.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Petasis, Pflugfelder, and Gamache. Claims 6-9,
and 13 fall with claim 1.
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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